Misoprostol in addition to routine treatment of postpartum hemorrhage: A hospital-based randomized-controlled trial in Karachi, Pakistan

Zuberi, Nadeem F.; Durocher, Jill; Sikander, Rozina; Baber, Neelofur; Blum, Jennifer; Walraven, Gijs

doi:10.1186/1471-2393-8-40

Cited by 33 publications

(39 citation statements)

References 20 publications

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“…In addition, approximately 5% of women bled ≥350 ml in secondary prevention clusters, which is lower than the 25% hypothesised based on prior studies 13. The reasons for the low levels of bleeding in this study are unclear, although other studies document low or declining measured ‘PPH rates’ during study recruitment, thought to be due to increased provider confidence and training 21, 22, 23, 24, 25. In compliance with government policy, ANMs referred high‐risk deliveries to higher‐level facilities, and women enrolled may have constituted a low‐risk population, although numerous studies have shown that it is difficult to identify the majority of women who will experience PPH based on pre‐existing risk factors.…”

Section: Discussionmentioning

confidence: 50%

Misoprostol for primary versus secondary prevention of postpartum haemorrhage: a cluster‐randomised non‐inferiority community trial

Raghavan

Geller

Miller

et al. 2015

BJOG

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ObjectiveTo assess whether secondary prevention, which preemptively treats women with above‐average postpartum bleeding, is non‐inferior to universal prophylaxis.DesignA cluster‐randomised non‐inferiority community trial.SettingHealth sub‐centres and home deliveries in the Bijapur district of Karnataka, India.PopulationWomen with low‐risk pregnancies who were eligible for delivery with an Auxiliary Nurse Midwife at home or sub‐centre and who consented to be part of the study.MethodsAuxiliary Nurse Midwifes were randomised to secondary prevention using 800 mcg sublingual misoprostol administered to women with postpartum blood loss ≥350 ml or to universal prophylaxis using 600 mcg oral misoprostol administered to all women during the third stage of labour.Main outcome measuresPostpartum haemoglobin ≤7.8 g/dl, mean postpartum blood loss and postpartum haemoglobin, postpartum haemorrhage rate, transfer to higher‐level facilities, acceptability and feasibility of the intervention.ResultsMisoprostol was administered to 99.7% of women as primary prevention. In secondary prevention, 92 (4.7%) women had postpartum bleeding ≥350 ml, of which 90 (97.8%) received misoprostol. The proportion of women with postpartum haemoglobin ≤7.8 g/dl was 5.9 and 8.8% in secondary and primary prevention clusters, respectively [difference −2.9%, one‐sided 95% confidence interval (CI) <1.3%]. Postpartum transfer and haemorrhage rates were low (<1%) in both groups. Shivering was more common in primary prevention clusters (P = 0.013).ConclusionSecondary prevention of postpartum haemorrhage with misoprostol is non‐inferior to universal prophylaxis based on the primary outcome of postpartum haemoglobin. Secondary prevention could be a good alternative to universal prophylaxis as it medicates fewer women and is an acceptable and feasible strategy at the community level.Tweetable abstractSecondary prevention of postpartum haemorrhage with misoprostol is non‐inferior to universal prophylaxis.

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Section: Discussionmentioning

confidence: 50%

Misoprostol for primary versus secondary prevention of postpartum haemorrhage: a cluster‐randomised non‐inferiority community trial

Raghavan

Geller

Miller

et al. 2015

BJOG

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“…The three published trials (31)(32)(33) were relatively small, with a total of 465 women participating. The unpublished WHO-Gynuity trial (34) included 1400 women in Argentina, Egypt, South Africa, Thailand and Viet Nam.…”

Section: Summary Of Evidencementioning

confidence: 99%

“…The unpublished WHO-Gynuity trial (34) included 1400 women in Argentina, Egypt, South Africa, Thailand and Viet Nam. In three trials (31,33,34), 600 µg of misoprostol was administered orally or sublingually, while in the fourth trial (32) 1000 µg was administered orally, sublingually or rectally. The results of the WHO-Gynuity trial (34) were presented to the Consultation and are included in the GRADE table (page 28, GRADE Table B1).…”

Section: Summary Of Evidencementioning

confidence: 99%

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Augensen¹

2010

Tidsskriftet

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“…Since 1987, misoprostol has been used to prevent or treat PPH in doses up to 600 µg in oral or sublingual administration [8][9][10] and up to 1000 µg rectally [11][12][13][14][15][16]. Misoprostol tablet can also be absorbed by both rectal and vaginal routes [17].…”

Section: Introductionmentioning

confidence: 99%

Development of Misoprostol Suppositories for Postpartum Hemorrhage

Constantin

Zelger²,

Paroz³

et al. 2013

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Misoprostol is a prostaglandin E1 analogue used to prevent and treat gastric ulcers. It has been commonly used in gynecology and obstetrics, especially for the management of postpartum hemorrhage (PPH). For this purpose, 1000 μg intrarectal (insertion of five 200 μg tablets) has been recommended as the third line after injectable oxytocin and methylergometrine. We proposed to manufacture a 1000 μg misoprostol suppository by determining formulation, release and stability. The administration facility was also evaluated. Several formulations of misoprostol suppositories were set up and evaluated. Misoprostol tablets and lipophilic bases (Hard fat-Adeps solidus Ph. Eur., Witepsol ® H15 and Suppocire ® AM and AS 2 X) were used to obtain suppositories. Surfactants were also tested (polysorbates Tween ® 20, Tween ® 80 and sodium lauryl sulfate (SLS)). The formula was monitored by the misoprostol release curve with an in vitro test and dosed by a HPLC method. Stability was determined by evaluating the percentage of misoprostol content remaining over the time in suppositories stored at 4˚C and 25˚C. Facility of use versus tablets was evaluated by obstetricians of a Swiss regional hospital using a questionnaire. Misoprostol release was facilitated by adding surfactant to the lipophilic base. After 30 minutes, 59% ± 1.4% and 57% ± 8.2% of misoprostol was released with Adeps solidus + 1% SLS and Adeps solidus + 5% Tween 20 respectively. SLS was discarded to the final formula because of its irritating effect. After 7 months, suppositories still contained 94% ± 3.7% misoprostol with storage at 4˚C. The administration was considered easier and faster compared with intra rectal use of tablets. The formula, consisting of 5 crushed misoprostol tablets dispersed in a suppository base made of Adeps solidus + 5% Tween ® 20, is stable for at least 7 months at 4˚C and facilitates the rectal administration of misoprostol in the treatment of PPH.

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Misoprostol in addition to routine treatment of postpartum hemorrhage: A hospital-based randomized-controlled trial in Karachi, Pakistan

Cited by 33 publications

References 20 publications

Misoprostol for primary versus secondary prevention of postpartum haemorrhage: a cluster‐randomised non‐inferiority community trial

Misoprostol for primary versus secondary prevention of postpartum haemorrhage: a cluster‐randomised non‐inferiority community trial

Nyttig bidrag for å redusere mødredødelighet

Development of Misoprostol Suppositories for Postpartum Hemorrhage

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