Emad Darwish

Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women not exposed to oxytocin during labour: a double-blind, randomised, non-inferiority trial.

BACKGROUND Oxytocin, the standard of care for treatment of post-partum haemorrhage, is not available in all settings because of refrigeration requirements and the need for intravenous administration. Misoprostol, an effective uterotonic agent with several advantages for resource-poor settings, has been investigated as an alternative. This trial established whether sublingual misoprostol was similarly efficacious to intravenous oxytocin for treatment of post-partum haemorrhage in women not exposed to oxytocin during labour. METHODS In this double-blind, non-inferiority trial, 9348 women not exposed to prophylactic oxytocin had blood loss measured after vaginal delivery at four hospitals in Ecuador, Egypt, and Vietnam (one secondary-level and three tertiary-level facilities). 978 (10%) women were diagnosed with primary post-partum haemorrhage and were randomly assigned to receive 800 microg misoprostol (n=488) or 40 IU intravenous oxytocin (n=490). Providers and women were masked to treatment assignment. Primary endpoints were cessation of active bleeding within 20 min and additional blood loss of 300 mL or more after treatment. Clinical equivalence of misoprostol would be accepted if the upper bound of the 97.5% CI fell below the predefined non-inferiority margin of 6%. All outcomes were assessed from the time of initial treatment. This study is registered with ClinicalTrials.gov, number NCT00116350. FINDINGS All randomly assigned participants were analysed. Active bleeding was controlled within 20 min with study treatment alone for 440 (90%) women given misoprostol and 468 (96%) given oxytocin (relative risk [RR] 0.94, 95% CI 0.91-0.98; crude difference 5.3%, 95% CI 2.6-8.6). Additional blood loss of 300 mL or greater after treatment occurred for 147 (30%) of women receiving misoprostol and 83 (17%) receiving oxytocin (RR 1.78, 95% CI 1.40-2.26). Shivering (229 [47%] vs 82 [17%]; RR 2.80, 95% CI 2.25-3.49) and fever (217 [44%] vs 27 [6%]; 8.07, 5.52-11.8) were significantly more common with misoprostol than with oxytocin. No women had hysterectomies or died. INTERPRETATION In settings in which use of oxytocin is not feasible, misoprostol might be a suitable first-line treatment alternative for post-partum haemorrhage.

A randomized controlled trial of 400‐μg sublingual misoprostol versus manual vacuum aspiration for the treatment of incomplete abortion in two Egyptian hospitals

To compare the safety, efficacy, and acceptability of 400‐μg sublingual misoprostol with that of manual vacuum aspiration (MVA) in 2 Egyptian hospitals.

Clinical evaluation of two monthly injectable contraceptives and their effects on some metabolic parameters

One-hundred-and-thirty normally menstruating females were subgrouped equally and enrolled from the family planning clinic to study the clinical performance of the monthly injectable contraceptives medroxyprogesterone acetate 25 mg + estradiol cypionate 5 mg (Cycloprovera) and norethisterone enanthate 50 mg + estradiol valerate 5 mg (HRP-102) and their effects on some metabolic parameters. The contraceptive efficacy after 6 months of use for both drugs was 100%. No change in menstrual pattern occurred in 74% of Cycloprovera users and 67.3% of HRP-102 users. A statistically significant decrease (P less than 0.01) occurred in HDL-cholesterol and total serum protein values and a statistically significant increase (P less than 0.01) was observed in hematocrit value of Cycloprovera users only. Body weight and blood pressure values after 6 months of drug use showed no statistically significant changes in both groups. Also, no statistically significant changes were noticed in both groups for hemoglobin, post-prandial blood glucose, cholesterol, A/G ratio, SGPT and SGPT values following 6 months of injectable contraceptive use. None of the injectable users developed cervical dysplastic changes cytologically.

Study of serum copper and zinc in cases of hyperemesis gravidarum

The dehydration, electrolyte and metabolic changes which occur in hyperemesis gravidarum are well recognized. The aim of this paper was to study the changes in serum copper and zinc and their correlation with the changes in serum electrolytes that occur in patients with hyperemesis gravidarum. Serum copper, zinc, sodium and potassium and urinary chloride were measured in 30 patients suffering from hyperemesis gravidarum and compared to the levels in 10 normal pregnant women in their first trimester. There was no significant change in serum copper or zinc in patients with hyperemesis compared to normal pregnant women. Also, there was no significant correlation between the changes in the level of these trace elements and the decrease which occurred in serum sodium and potassium and urinary chloride.

Cervical prostaglandin injection: a novel method of administration for ripening the cervix and induction of labor

Twenty pregnant women with ⩾36 weeks gestation and Bishop score of ⩽4 were subjected to either intracervical injection of PGE2 (0.25 mg) every 4 h to ripen the cervix and induce labor (study group n = 10) or injection of only the diluent (control group n = 10). PGE2 cases showed significant increase in Bishop score and were successfully induced. The mean induction‐establishment and induction‐delivery intervals were 4.3 ± 0.1 min and 6.07 ± 1.7 h, respectively. The control group showed no response. PGE2 cervical injection is a safe and effective method for cervical ripening and labor induction.

Low dose acetyl salicylic acid in severe preeclampsia

Twenty pregnant patients in the third trimester with severe preeclampsia were allocated at random into two equal groups. The first group was treated for 10 days with a low dose (75 mg/day) of acetyl salicylic acid (ASA) then with conventional therapy for another 10 days. The second group received the same regimen but conventional therapy in the first 10 days and ASA in the second 10 days. Changes in systolic and diastolic blood pressure, albuminuria, lower limb edema and urinary output were closely monitored and recorded. This comparative crossover study indicated that both the low dose ASA and conventional therapy significantly reduced systolic and diastolic blood pressure which was more pronounced with ASA and in group I. Crossover from one treatment to the other maintained the response but was more beneficial when ASA was given first.

Induction of labor by oral prostaglandin E2 in protracted pregnancy.

Induction of labor was performed in 20 pregnant females with postmaturity (> 294 days) using either oral PGE2 tablets (0.5 mg) or i.v. oxytocin drip (each group n = 10). The induction‐establishment interval was significantly shorter in the oxytocin group (P < 0.005). Moreover, the uterine activity (in Alexandria units) at 3 h post‐induction and at the end of the first stage of labor, was significantly higher with i.v. oxytocin (P < 0.005). However, the induction‐delivery interval did not differ in both groups. All cases delivered spontaneously with a satisfactory Apgar score.

Urinary hormonal profile during the first cycle of low-dose oral contraceptive pills in women

Ovarian function was studied in ten normal fertile women before and during the first cycle on a low-dose micropill containing 30 mcg ethinyl estradiol and 150 mcg L-norgestrel. In a control cycle and the first treatment cycle, steroid metabolites estrone-3-glucuronide (E1-3G) and pregnanediol-3 alpha-glucuronide (Pd-3G) were measured in daily early morning urine (EMU) samples. Also, luteinizing hormone (LH) was estimated during the expected periovulatory period. During the first cycle of micropill intake, ovarian function was suppressed in all cases. This is evidenced by significantly lower E1-3G and Pd-3G and absent midcycle LH peak compared to control cycles. The pattern of steroid metabolites was almost flat with no peaks. It is concluded that there is no need to cover the first cycle of micropill intake with other contraceptive methods.