CHAPTER 6 OBSTETRICS AND GYNAECOLOGY NATIONAL DEPARTMENT OF
CHAPTER 6: OBSTETRICS AND GYNAECOLOGY NATIONAL DEPARTMENT OF HEALTH AFFORDABLE MEDICINES ESSENTIAL MEDICINES PROGRAMME PRIMARY HEALTHCARE 2014 Updates to the 2008 PHC STG & EML
6. 1. 1 MISCARRIAGE Added text: • “For patients with safe miscarriage need for referral will be determined by skills & facilities at the primary health care level. A local referral policy should be negotiated accordingly. Ideally midwife obstetric units & community health centres should be able to manage safe miscarriage using manual vacuum aspiration”. – New STG added: 6. 1. 2. 1 INCOMPLETE MISCARRIAGE IN THE FIRST TRIMESTER (≤ 12 WEEKS GESTATION) PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 2
6. 1. 2. 1 INCOMPLETE MISCARRIAGE IN THE FIRST TRIMESTER (≤ 12 WEEKS GESTATION) • Misoprostol: added – Before MVA, to ripen the cervix: • Misoprostol, oral/vaginal, 400 mcg as a single dose. • – Medical evacuation: • Misoprostol, oral/vaginal, 600 mcg as a single dose. – Repeat after 24 hours if necessary. • Follow up after one week to ensure that bleeding has stopped. Note: As silent miscarriage requires diagnosis by ultrasound imaging, management was not included for primary level of care. Level of Evidence: III Guidelines Ref 1 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 3
6. 4 PRELABOUR RUPTURE OF MEMBRANES AT TERM (PROM) • Ampicillin IV: added • Metronidazole, oral: added • Erythromycin, oral: not added pture u r r u relabo erm P = PROM ranes at t mb e m f o erm t e r P of M= PPRO ur rupture o prelab nes ra memb – Prolonged rupture of membranes present regularly at clinics & are not managed appropriately. – Oracle study evaluated antibiotics for the management of PPROM, not PROM. Erythromycin cannot be used in the setting of PROM at term. The PHC STG recommends referral of all cases of PPROM. Level of Evidence: III Guidelines PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY Ref 2 4
6. 7. 2 MASTITIS • Flucloxacillin: added • Azithromycin: added • Paracetamol: added – Condition commonly presents at primary level. – Mastitis is a focal infection of breast tissue & infectious mastitis only occurs when milk ducts are infected. The STG recommends breastfeeding be stopped when a breast abscess has developed, requiring referral for incision and drainage. Level of Evidence: III Expert opinion PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 5
CHRONIC HYPERTENSION Prevention of pre-eclampsia • Aspirin: added • Calcium: added Treatment • Methyldopa: added – Ease of reference for healthcare workers at PHC level. – Poorly controlled hypertension & chronic hypertension superimposed with pre-eclampsia be referred to secondary level of care. Level of Evidence: III Guidelines Ref 3 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 6
AMENDMENTS 2014 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 7
6. 1. 1 MISCARRIAGE • Ceftriaxone: caution amended – Revised FDA warning: risk of calcium-ceftriaxone precipitation is low in adults. Ceftriaxone calcium-containing products may be administered sequentially. In Rh-negative, non sensitised women • Anti-D immunoglobulin, IM: dose retained – The usual dose is 50 mcg before 20 weeks & 100 mcg after 20 weeks, but only 100 mcg vial is available on the South African market. Once the vial is opened, it must be used within 24 hours. Level of Evidence: III Expert opinion Ref 4 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 8
6. 1. 3 ANTEPARTUM HAEMORRHAGE • Sodium chloride 0. 9%, IV: amended – Following text was amended: » “Avoid vaginal examination, unless placenta praevia excluded”. • Prostaglandins: caution box deleted – Antepartum haemorrhage is not managed at primary level. All patients are referred. Level of Evidence: III Expert opinion PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 9
6. 2. 1 CARE OF HIV-INFECTED PREGNANT WOMAN Aligned with NDo. H ARV Guidelines Women on ART with no symptoms of TB: • Isoniazid: added – Evidence supporting 12 months IPT for HIV adults on ART extrapolated to pregnant women, as there is no available evidence in pregnancy. – Cohort study demonstrates: TB incidence in patients on ART: IF ADMINISTERED 12 MONTHS IPT Level of Evidence: II, III RCT, Guidelines PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY Ref 5 10
6. 2. 1 CARE OF HIV-INFECTED PREGNANT WOMAN • Pyridoxine: added – Supporting evidence for pyridoxine supplementation of INH therapy is of poor quality. RCT data is lacking, but this recommendation is included in most guidelines. Level of Evidence: III Guidelines, Case reports Ref 6 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 11
6. 2. 1 CARE OF HIV-INFECTED PREGNANT WOMAN Women with CD 4 counts ≤ 200 cells/mm 3 or WHO clinical stage 2, 3 or 4 • Cotrimoxazole, 160/800 mg: added – Daily, until CD 4 counts > 200 cells/mm 3. Pre-emptive therapy for cryptococcal meningitis: • Fluconazole: added Level of evidence: III Guidelines Ref 7 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 12
6. 2. 1 CARE OF HIV-INFECTED PREGNANT WOMAN Safety of fluconazole in HIV infected pregnant women. • FDA (2011): reclassified long-term, high dose (400 -800 mg) k D-ris daily fluconazole therapy > k C-ris – 11 case reports of congenital anomalies in babies (mothers administered fluconazole during 1 st trimester). CATEGORY C CATEGORY D • Subsequent Danish registry-based cohort: – Fluconazole in 1 st trimester not associated with a significantly increased risk of birth defects overall. • A concern: Tetralogy of Fallot - OR 3. 2 (95% CI 1. 5 to 6. 8). Level of Evidence: III Registry study Ref 8 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 13
6. 2. 1 CARE OF HIV-INFECTED PREGNANT WOMAN Antiretroviral therapy • • Zidovudine: retained Nevirapine: retained Tenofovir: added Emtricitabine: added Efavirenz: added Lamivudine: added Lopinavir/ritonavir: added Level of evidence: III Guidelines Ref 9 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 14
6. 2. 1 CARE OF HIV-INFECTED PREGNANT WOMAN ADDITIONAL POINTS If active psychiatric conditions present (in consultation with doctor): • CD 4 ≤ 250: Replace EFV NVP – BUT: IF ALT ABNORMAL: EFV LPV/r • ALT > 100 IU/L, refer to secondary level. • CD 4 > 250: Replace EFV LPV/r Level of Evidence: III Guidelines, Expert opinion Ref 10 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 15
6. 2. 1 CARE OF HIV-INFECTED PREGNANT WOMAN Renal dysfunction • Zidovudine: deleted • Abacavir: added – Aligned with PMTCT Sub-Committee recommendations to switch TDF ABC • AZT associated with anaemia. Level of Evidence: III Expert opinion PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 16
6. 2. 1 CARE OF HIV-INFECTED PREGNANT WOMAN For unbooked women diagnosed in labour • Nevirapine: indications amended • Indicated early as possible in labour (vaginal delivery) Level of Evidence: III Expert opinion Ref 11 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 17
6. 2. 1 CARE OF HIV-INFECTED PREGNANT WOMAN Unbooked women diagnosed in labour who are to breastfeed • Intrapartum: NVP+TDF+FTC as a stat dose, followed by AZT 3 -hourly until delivery (unbooked women diagnosed in labour) THEN • Postnatal: Switch to TDF+FTC+EFV+TDF – NVP protects against vertical HIV transmission (MTCT). Postnatal ART is commenced within 24 hours after delivery to prevent MTCT during breastfeeding. Level of Evidence: III Guidelines Ref 12 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 18
6. 2. 1 CARE OF HIV-INFECTED PREGNANT WOMAN Baby • Cross referenced to Section 11. 4. 1: The HIV exposed infant. Level of Evidence: III Guidelines PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 19
6. 2. 2 HYPERTENSIVE DISORDERS OF PREGNANCY MILD HYPERTENSION • Nifedipine XL 30 mg: deleted : ry C ow o g e Cat dies sh o A FD l stu &n t c a e f l m Ani erse ef & wel in adv equate tudies. ad lled s men wo tro con gnant pre – Limited efficacy and safety data for nifedipine longacting and amlodipine in pregnancy. – Both are FDA category C medicines. – National Maternity Guidelines recommends methyldopa as 1 st line therapy for hypertension in pregnancy. Level of evidence: III Guidelines PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY Ref 13 20
6. 2. 2 HYPERTENSIVE DISORDERS OF PREGNANCY • Methyldopa: amended- drug interaction added – Oral iron markedly reduces the absorption of methyldopa. Level of evidence: III Guidelines Ref 14 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 21
6. 2. 2 HYPERTENSIVE DISORDERS OF PREGNANCY SEVERE HYPERTENSION • Nifedipine, 10 mg: dosing interval retained – Dosing interval retained as “hourly” • Aligned with Adult Hospital level STG, 2012. Level of evidence: III Guidelines Ref 15 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 22
6. 2. 2 HYPERTENSIVE DISORDERS OF PREGNANCY ECLAMPSIA • Magnesium sulphate, IV: directions for use amended – Immediate transfer to secondary level, is always planned for eclamptics. – The STG only recommends the Pritchard loading dose of Magnesium sulphate, IV. – Maintenance continued by infusion once the patient has reached hospital. Level of Evidence: III Expert opinion PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 23
6. 2. 2 HYPERTENSIVE DISORDERS OF PREGNANCY CHRONIC HYPERTENSION Prevention of pre-eclampsia • Calcium: added for all pregnant women • Aspirin: added as doctor initiated for women with historical risk factors of preeclampsia – “Chronic hypertension” STG added for ease of reference for healthcare workers at PHC level. – Meta-analysis (n=12416) showed that daily aspirin, 50 -150 mg significantly reduced rates of perinatal death and preeclampsia in women at high risk of preeclampsia (i. e. history of preeclampsia, chronic hypertension, kidney disease, diabetes, etc). – Cochrane review: calcium supplementation (≥ 1 g/day) is associated with a significant reduction in the risk of pre-eclampsia, particularly for women with low calcium diets; reduction in preterm birth and the occurrence of the composite outcome ’maternal death or serious morbidity’. – Hypertensive disorders are a leading cause of maternal mortality in South Africa. – High rate of dietary calcium deficiency has been reported (median < 600 mg daily) amongst women attending State hospitals in Gauteng and the Eastern Cape. Level of Evidence: I Meta-analysis PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY Ref 16 24
6. 2. 2 HYPERTENSIVE DISORDERS OF PREGNANCY CHRONIC HYPERTENSION Treatment of chronic hypertension • Methyldopa: added – “Chronic hypertension” STG added for ease of reference for healthcare workers at PHC level. – Poorly controlled hypertension & chronic hypertension superimposed with pre-eclampsia referred. Rationale: National Maternity Guidelines recommends methyldopa as first line therapy for treatment of hypertension in pregnancy. Level of Evidence: III Guidelines PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY Ref 17 25
6. 2. 3 ANAEMIA IN PREGNANCY • Ferrous sulphate: directions for use amended • Ferrous fumarate: added • Ascorbic acid: not added - The following text was added: Do not take iron tablets within 4 hours of taking calcium tablets - Continual stock outs of iron tablets warranted that ferrous fumarate be added to the STG. High dose of iron supplementation not considered safe in this clinical setting. Level of Evidence: III Expert opinion Ref 18 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 26
6. 2. 3 ANAEMIA IN PREGNANCY REFERRAL • Criteria corrected for pragmatic purposes. • Hb < 7 g/d. L in women who have not responded to oral therapy, after a month. • Women > 34 weeks gestation with Hb < 7 g/d. L. • Any low Hb with an obstetric complication. • Pallor (anaemia) plus signs of chronic disease, e. g. suspicion of TB, or the presence of hepatosplenomegaly. • Anaemia of sudden onset. PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 27
6. 2. 4 SYPHILIS IN PREGNANCY PREGNANT WOMAN • Benzathine benzylpenicillin: directions for reconstitution amended • Lidocaine 1%: added – To reduce pain on administration of benzathine benzylpenicillin, IM injection. – Aligned with the rheumatic fever STG. – Pragmatic purposes: 6 m. L lidocaine 1%. Level of Evidence: III Expert opinion, Guidelines Ref 19 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 28
6. 2. 4 SYPHILIS IN PREGNANCY PENICILLIN ALLERGY • Doxycycline: deleted • Erythromycin: deleted – Pregnant women with penicillin allergy referred to secondary level, for penicillin desensitisation. • Aligned with Adults Hospital level STG, 2012. Level of Evidence: III Guidelines Ref 20 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 29
6. 2. 4 SYPHILIS IN PREGNANCY NEWBORN BABY Aligned with the 2010 CDC STI guidelines. – Outlines medicine management: 1. Symptomatic newborn baby. 2. Asymptomatic newborn baby. i. iii. Mother not treated. Mother received < 3 doses of benzylpenicillin. Mother delivers within 4 weeks of starting treatment for syphilis. Level of Evidence: III Guidelines Ref 21 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 30
6. 2. 4 SYPHILIS IN PREGNANCY ASYMPTOMATIC NEWBORN BABY • Benzathine benzylpenicillin: retained • Procaine penicillin: deleted • Lidocaine 1%: not added – WHO & CDC recommend single dose of benzathine benzylpenicillin for asymptomatic newborn babies, with no need for follow up. – Safety of lidocaine 1% as a local anaesthetic not established in newborn babies. Level of Evidence: III Guidelines, Expert opinion Ref 22 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 31
6. 2. 4 SYPHILIS IN PREGNANCY SYMPTOMATIC NEWBORN BABY • Procaine penicillin: not added • Benzylpenicillin: not added – All symptomatic newborns of mothers with syphilis are referred. • To ensure CSF is negative EXAMPLES OF SYMPTOMATIC BABIES: – Hepatosplenomegaly – Desquamative rash (especially palms & soles) – Snuffles – Jaundice – Pseudoparesis – Oedema – Anaemia Level of Evidence: III Expert opinion PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 32
6. 3. 1 PRETERM LABOUR (PTL) Tocolyisis • Nifedipine: directions for use amended – Follow on doses only if contractions persist, until patient is transferred. – Aligned with Adult Hospital level STG, 2012. Level of Evidence: III Guidelines Ref 23 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 33
6. 4 PRELABOUR RUPTURE OF MEMBRANES AT TERM (PROM) • Erythromycin: not added – The Oracle study evaluated antibiotics for the management of p. PROM not PROM. Therefore, erythromycin cannot be used in the setting of PROM at term. The PHC STG recommends referral of all cases of p. PROM. Level of Evidence: I RCT Ref 24 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 34
6. 5 INTRAPARTUM CARE First stage with cervical dilatation < 10 cm Analgesia • Morphine, IM: dose amended to 10 mg – Analgesia dose of 10 mg morphine = 100 mg pethidine – Dose of 15 mg would probably introduce risk rather than benefit Level of Evidence: III Expert opinion PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 35
6. 5 INTRAPARTUM CARE Fetal distress during labour • Salbutamol: retained – Although chronic use of salbutamol is associated with myocardial infarction and ischaemia, a single dose is used in this clinical setting. – Benefit outweighs risk in this clinical setting. Level of Evidence: III Expert opinion PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 36
6. 5 INTRAPARTUM CARE Inadequate or inco-ordinate uterine contractions • Oxytocin: deleted – Not considered pragmatic to recommend oxytocin augmentation at primary level. – Section deleted. Level of Evidence: III Expert opinion PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 37
6. 5 INTRAPARTUM CARE Post-partum haemorrhage (PPH) • Oxytocin: retained & directions for use amended • Ringers- Lactate: deleted • Sodium chloride, 0. 9%: added – Aligned with the Essential Steps in Managing Obstetric Emergencies (ESMOE) guidelines. – Systematic review that suggested superiority of oxytocin over misoprostol for vaginal births. Misoprostol was considered more toxic. Level of Evidence: I, III Systematic Review, Guidelines Ref 25 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 38
6. 5 INTRAPARTUM CARE If no response to oxytocin • Ergometrine: prescriber level & precaution amended • Oxytocin/Ergometrine: added – Midwives are trained in the use of ergometrine and should not be restricted to doctor initiated. – Amended to align with the Adult Hospital level STG, 2012 and ergometrine package insert. – Avoid ergometrine in heart disease, unless haemorrhage is life threatening. Level of Evidence: III Guidelines, Expert opinion Ref 26 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 39
6. 5 INTRAPARTUM CARE Only in settings where oxytocin is not available • Misoprostol: retained & prescriber level & dose amended – Most primary care clinics do not have doctors in maternity and are run by midwives. – ESMOE, FIGO, National Maternity Guidelines, and WHO guidelines recommend misoprostol for treatment of post-partum haemorrhage only when no oxytocin is available. – Oxytocin requires refrigeration. – Where stock-outs of oxytocin occur, misoprostol should be made available (Maternal mortality countered). – Dose amended from “ 400 mcg” to “ 600 mcg”, aligned with WHO 2012 recommendations. Level of Evidence: III Guidelines, Expert opinion Ref 27 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 40
6. 5 INTRAPARTUM CARE Note for HIV positive patients: deleted – The message regarding episiotomy is the same for all women in labour irrespective of HIV status. Level of Evidence: III Expert opinion PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 41
6. 6. 1 ROUTINE CARE OF THE NEONATE • Aligned with the South African Initiative for Newborn Care, previously known as the Limpopo Initiative for Newborn Care. PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 42
6. 6. 2 NEONATAL RESUSCITATION • Aligned with the current SAPA handbook & Resuscitation Council’s algorithm for newborn resuscitation, relevant to primary care level. • The following three questions to evaluate the infant were retained in the text of the STG, – 1. Is the baby breathing adequately and not just gasping? – 2. Is the baby’s heart rate (HR) > 100 beats/minute? – 3. Is the baby centrally pink, i. e. no central cyanosis? ” Level of Evidence: III Guidelines PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY Ref 28 43
6. 7. 1 CRACKED NIPPLES DURING BREASTFEEDING • Nystatin: added • Zinc and castor oil ointment: added – Cross referenced to Section 1. 2: Candidiasis, oral (thrush) for the management of neonatal oral thrush in this clinical setting. – Zinc and castor oil ointment, applied between feeds Level of evidence: III Guidelines, Expert opinion PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 44
6. 8. 1 ABNORMAL VAGINAL BLEEDING DURING FERTILE YEARS • Ibuprofen: dose amended – Dose amended from “ 200– 400 mg 8 hourly” to “ 400 mg 8 hourly”. – Aligned with the Adult Hospital level STGs and EML, 2012. Level of evidence: III Guidelines Ref 29 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 45
6. 11 HORMONE REPLACEMENT THERAPY (HT) Level of evidence: III Guidelines Ref 30 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY R 30, 90 – FDC: estradiol valerate 2 mg + cyproterone acetate cheaper than R 90, 00 conj. estrogens 0. 3 mg + MPA 10 mg R 80, 00 – Text aligned with the Adult Hospital R 70, 00 level STG and EML, 2012 edition. R 60, 00 $88, 62 Sequentially opposed therapy: • Cyproterone acetate, oral, 1 mg: added • Norethisterone acetate, oral 1 mg: added • Medroxyprogesterone acetate, oral: dose amended FDC: Estradol val + Cyprotero ne R 50, 00 Conj. R 40, 00 Estrogen 0. 3 mg + R 30, 00 MPA 10 R 20, 00 mg R 10, 00 RPrice comparison 46
6. 11 HORMONE REPLACEMENT THERAPY (HT) Continuous combined therapy • Text aligned with Adult Hospital level STG, 2012. Women with no uterus (post-hysterectomy): • Estradiol valerate, oral: dose amended • Conjugated estrogens, oral: directions for use amended – Aligned with the Adult Hospital level STG, 2012. Level of evidence: III Guidelines Ref 31 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 47
6. 11 HORMONE REPLACEMENT THERAPY (HT) • Considered impractical to refer all HT cases to secondary level facilities, burdening these facilities with patients that can be managed at primary level of care. • STG recommends that HT only be indicated for “Short term symptomatic relief for severe menopausal symptoms”. – Mammogram done at commencement of HT, and then once a year, if available. PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 48
6. 11 HORMONE REPLACEMENT THERAPY (HT) Safety of cyproterone • Studies show that venous thrombolic events occur 3 times more frequently with levonorgestrel within the first year compared with nonusers. • This risk increases to 6 -fold with newer generation progestogens. – Extrapolation of data regarding VTE coincident with cyproterone amongst young women, using cyproterone as contraceptives, to menopausal women using cyproterone for HT considered inappropriate. – No clear data was available for different progestogens on the risk of VTE. • Cyproterone is not recommended for contraception in the PHC STG. • Dose of 1 mg is administered for 10 days. • Recommended duration of therapy is limited to five years. Level of evidence: III Expert opinion Ref 32 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 49
CASE STUDY 26 year old G 2 P 1 18 wks pregnant female came for a pre-natal visit at the clinic. She is single, unemployed and lives with her children. She is on chronic methyldopa to manage her blood pressure. During her last pregnancy she was induced at 37 wks due to severe HELLP syndrome*. She is not taking prenatal vitamin and has a history of lactose intolerance. What medication would you prescribe for her? A. Aspirin B. Folic Acid C. Calcium D. All of the above (* HELLP syndrome is characterized by haemolysis, abnormal aminotransferases, and a low platelet count. It occurs in 5% of women with preeclampsia, although it can develop as a separate entity in the absence of preeclampsia. Egerman RS, Sibai BM. HELLP syndrome. Clin Obstet Gynecol. 1999; 42: 381 -389). PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 50
CASE STUDY - SOLUTION A. B. C. D. Aspirin Folic Acid Calcium All of the above – Aspirin for moderate to high risk of preeclampsia. – Calcium for low intake in diet & high risk patients of preeclampsia. PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 51
Slide Ref # Reference 6. 1. 2. 1 INCOMPLETE MISCARRIAGE IN THE FIRST TRIMESTER (≤ 12 WEEKS GESTATION) 3 1 MISOPROSTOL • Adult Hospital level STG, 2012 6. 4 PRELABOUR RUPTURE OF MEMBRANES AT TERM (PROM) 4 2 • Adult Hospital level STG, 2012 • Kenyon SL, Taylor DJ, Tarnow-Mordi W; ORACLE Collaborative Group. Broad-spectrum antibiotics for preterm, prelabour rupture of fetal membranes: the ORACLE I randomised trial. ORACLE Collaborative Group. Lancet. 2001 Mar 31; 357(9261): 979 -88. CHRONIC HYPERTENSION 6 3 • Adult Hospital level STG, 2012 • National Department of Health, Republic of South Africa. 2014. Guidelines for Maternity care in South Africa, 4 th edition. 6. 1. 1 MISCARRIAGE 8 4 CEFTRIAXONE • FDA safety alert: Ceftriaxone, 21 April 2009. Available at: http: //www. fda. gov/Drugs/Drug. Safety/Postmarket. Drug. Safety. Informationfor. Patientsand. Providers/Drug. Safety. Informationfor. Heathca re. Professionals/ucm 084263. htm 6. 2. 1 CARE OF HIV-INFECTED PREGNANT WOMAN 10 5 ISONIAZID • Rangaka MX, Boulle A, Wilkinson RJ et al. Randomized controlled trial of isoniazid preventive therapy in HIV-infected persons on antiretroviral therapy. THLBB 03 - Oral Abstract Session. XIX International AIDS Conference, 2012. Available at: http: //pag. aids 2012. org/Abstracts. aspx? AID=21471 6. 2. 1 CARE OF HIV-INFECTED PREGNANT WOMAN 11 6 PYRIDOXINE • Snider DE Jr. Pyridoxine supplementation during isoniazid therapy. Tubercle. 1980 Dec; 61(4): 191 -6. Carlson HB, Anthony EM, Russell WF jr, Middlebrook. G. Prophylaxis of isoniazid neuropathy with pyridoxine. N Engl J Med. 1956 Jul 19; 255(3): 119 -22. • Zilber LA, Bajdakova ZL, Gardasjan AN, Konovalov NV, Bunina TL, Barabadze EM. The prevention and treatment of isoniazid toxicity in therapy of pulmonary tuberculosis. 2. An assessment of the prophylactic effect of pyridoxine in low dosage. Bull World Health Organ. 1963; 29: 457 -81. • Carlson HB, Anthony EM, Russell WF Jr, Middlebrook G. Prophylaxis of isoniazid neuropathy with pyridoxine. N Engl J Med. 1956 Jul 19; 255(3): 119 -22. PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 52
Slide Ref # Reference 12 7 COTRIMOXAZOLE and FLUCONAZOLE • National Department of Health. National consolidated guidelines for the prevention of mother-to-child transmission of HIV (PMTCT) and the management of HIV in children, adolescents and adults, 2014. 13 8 FLUCONAZOLE • Lopez-Rangel E, Van Allen MI. Prenatal exposure to fluconazole: an identifiable dysmorphic phenotype. Birth Defects Res A Clin. Mol. Teratol. 2005; 73: 919 -23. • Pursley TJ, Blomquist IK, Abraham J, Andersen HF, Bartley JA. Fluconazole-induced congenital anomalies in three infants. Clin Infect Dis. 1996; 22: 336 -40. • Lee BE, Feinberg M, Abraham JJ, Murthy AR. Congenital malformations in an infant born to a woman treated with fluconazole. Pediatr Infect Dis J. 1992; 11: 1062 -4. • Aleck KA, Bartley DL. Multiple malformation syndrome following fluconazole use in pregnancy: report of an additional patient. Am J Med Genet. 1997; 72: 253 -6. • Mølgaard-Nielsen D, Pasternak B, Hviid A. Oral fluconazole during pregnancy and risk of birth defects. N Engl J Med. 2013 Nov 21; 369(21): 2061 -2. 14 9 ZIDOVUDINE, NEVIRAPINE, TENOFOVIR, EMTRACITABINE • National Department of Health. National consolidated guidelines for the prevention of mother-to-child transmission of HIV (PMTCT) and the management of HIV in children, adolescents and adults, 2014. 15 10 ZIDOVUDINE, NEVIRAPINE, TENOFOVIR, EMTRACITABINE • National Department of Health. National consolidated guidelines for the prevention of mother-to-child transmission of HIV (PMTCT) and the management of HIV in children, adolescents and adults, 2014. 17 11 NEVIRAPINE • European Collaborative Study. Mother-to-child transmission of HIV infection in the era of highly active antiretroviral therapy. Clin Infect Dis. 2005 Feb 1; 40(3): 458 -65. 6. 2. 1 CARE OF HIV-INFECTED PREGNANT WOMAN 18 12 BREASTFEEDING • National Department of Health. National consolidated guidelines for the prevention of mother-to-child transmission of HIV (PMTCT) and the management of HIV in children, adolescents and adults, 2014. 6. 2. 2 HYPERTENSIVE DISORDERS OF PREGNANCY 20 13 NIFEDIPINE • SAMF, 10 th edition (2012) • Contract circular HP 09 -2014 SD, 1 Aug 2014 to 31 Jul 2016 • National Department of Health, Republic of South Africa. 2014. Guidelines for Maternity care in South Africa, 4 th edition. PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 53
Slide Ref # Reference 21 14 METHYLDOPA • SAMF, 10 th edition (2012) 22 15 24 16 CALCIUM • Adult Hospital level STG, 2012 • Hofmeyr GJ, Lawrie TA, Atallah AN, Duley L, Torloni MR. Calcium supplementation during pregnancy for preventing hypertensive disorders and related problems. Cochrane Database Syst Rev. 2014 Jun 24; 6: CD 001059. ASPIRIN • Coomarasamy A, Honest H, Papaioannou S, Gee H, Khan KS. Aspirin for prevention of preeclampsia in women with historical risk factors: a systematic review. Obstet Gynecol. 2003 Jun; 101(6): 1319 -32. 25 17 METHYLDOPA • National Department of Health, Republic of South Africa. 2014. Guidelines for Maternity care in South Africa, 4 th edition. • Adult Hospital level STG, 2012 NIFEDIPINE • Adult Hospital Guidelines, 2012 6. 2. 3 ANAEMIA IN PREGNANCY 26 18 FERROUS FUMARATE • Contract circular HP 09 -2014 SD 6. 2. 4 SYPHILIS IN PREGNANCY 28 19 BENZATHINE BENZYLPENICILLIN • MCC registered package insert for Bicillin® L-A 2, 4 Injection • PHC STG, 2014: Section 4. 9 Rheumatic fever, acute 29 20 PENICILLIN DESENSITISATION • Adult Hospital level STG, 2012 30 21 BENZATHINE BENZYLPENICILLIN • Workowski KA, Berman S; Centers for Disease Control and Prevention (CDC). Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep. 2010 Dec 17; 59(RR-12): 1 -110. Erratum in: MMWR Recomm Rep. 2011 Jan 14; 60(1): 18. Dosage error in article text. 31 22 BENZATHINE BENZYLPENICILLIN • MCC registered package insert for Bicillin® L-A 2, 4 Injection • WHO 2004 bulletin • CDC, 2006 statement PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 54
Slide Ref # Reference 6. 3. 1 PRETERMLABOUR (PTL) 33 23 NIFEDIPINE • Adult Hospital level STG, 2012. 6. 4 PRELABOUR RUPTURE OF MEMBRANES AT TERM (PROM) 34 24 ERYTHROMYCIN • Kenyon SL, Taylor DJ, Tarnow-Mordi W; ORACLE Collaborative Group. Broad-spectrum antibiotics for preterm, prelabour rupture of fetal membranes: the ORACLE I randomised trial. ORACLE Collaborative Group. Lancet. 2001 Mar 31; 357(9261): 979 -88. 6. 5 INTRAPARTUM CARE 38 25 OXYTOCIN • Tunçalp Ö, Hofmeyr GJ, Gülmezoglu AM. Prostaglandins for preventing postpartum haemorrhage. Cochrane Database of Systematic Reviews 2012, Issue 8. Art. No. : CD 000494. • Essential Steps in Managing Obstetric Emergencies, facilitator’s guide 39 26 ERGOMETRINE • Adult Hospital level STG, 2012 40 27 MISOPROSTOL • Essential Steps in Managing Obstetric Emergencies (ESMOE), facilitator’s guide • International Federation of Gynecology and Obstetrics. Treatment of Post-Partum Haemorrhage with Misoprostol. May 2012 • National Department of Health, Republic of South Africa. 2014. Guidelines for Maternity care in South Africa, 4 th edition. • Hofmeyr GJ et al. Misoprostol to prevent and treat postpartum haemorrhage: a systematic review and meta-analysis of maternal deaths and dose-related effects. Bulletin of the World Health Organization 2009; 87: 666 -677. doi: 10. 2471/BLT. 08. 055715 6. 6. 2 NEONATAL RESUSCITATION 43 28 NEONATAL RESUSCITATION • SAPA handbook • Resuscitation Council: Algorithm for newborn resuscitation 6. 8. 1 ABNORMAL VAGINAL BLEEDING DURING FERTILE YEARS 45 29 IBUPROFEN • Adult Hospital level STG, 2012 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 55
Slide Ref # Reference 6. 11 HORMONE REPLACEMENT THERAPY (HT) 46 30 ESTRADIOL VALERATE • Adult Hospital level STG, 2012 • Contract circular HP 09 -2014 SD 47 31 ESTRADIOL VALERATE and CONJUGATED ESTROGENS • Adult Hospital level STG, 2012 6. 11 HORMONE REPLACEMENT THERAPY (HT) 49 32 CYPROTERONE • Lidegaard O, Lokkegaard E, Svendsen AL, Agger C. Hormonal contraception and risk of venous thromboembolism: national followup study. BMJ 2009; 339: b 2890. • van Hylckama A, Helmelhorst FM, Vandenbroucke JP, et al. The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study. BMJ 2009; 339: b 2921. • Lidegaard O, Neilsen LH, Skovlund CW, et al. Risk of venous thromboembolism from use of oral contraceptives containing different progestogens and oestrogen doses: Danish cohort study 2001 -9. BMJ 2011; 343: d 6423. • Manzoli L, De Vito C, Marzuillo C, et al. Oral contraceptives and venous thromboembolism: a systematic review and meta-analysis. Drug Saf 2012; 35: 191 -205. • Seaman HE, de Vries CS, Farmer RDT. Venous thromboembolism associated with cyproterone acetate in combination with ethinyloestradiol: observational studies using the UK General Practice Research Database. Pharmacoepidemiol Drug Safe 2004; 13: 427 -436 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: OBSTETRICS & GYNAECOLOGY 56
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