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Misoprostol and Oxytocin in Uniject® for Postpartum Hemorrhage Prevention in Communities
Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin in Uniject®
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Rationale for Research: Approximately 30% of maternal deaths in India are attributed to postpartum hemorrhage (PPH). The most common cause of PPH is uterine atony (failure of the uterus to contract properly after childbirth). Administration of an uterotonic drug as active management in the third stage of labor (AMTSL) can significantly reduce the rate of PPH. Oxytocin is considered the drug of choice for prevention of PPH. However, it is not always feasible to administer parenteral Oxytocin in resource-poor settings given the cold storage, sterile equipment, skilled personnel, and administration requirements. Recently, Oxytocin in Uniject®, a pre-filled, non-refillable easy to use device with a single measured dose has been found to be equally effective and safer and more convenient to use than traditional needle and syringe.
Misoprostol has been explored for preventing PPH in settings where parenteral uterotonics are not yet available or feasible to use. In 2007, the World Health Organisation in its guidelines on prevention of PPH endorsed the administration of oral Misoprostol for PPH prevention by unskilled providers "trained in its use in settings where Active management of the third stage of labor (AMTSL) is not practiced".
In spite of the evidence of clinical safety and efficacy of oral Misoprostol and/or Oxytocin in Uniject® as universal PPH prevention drugs, to date, there have been no studies comparing the programmatic effectiveness of either technology on a large scale or in nationwide PPH prevention programs. To address this gap, the investigators plan to conduct a large community-based trial in collaboration with the Aga Khan Health Services, India.
Study Objectives: The study will assess the feasibility, cost, risks and benefits of use of oral Misoprostol and parenteral Oxytocin in Uniject® as prophylaxis for PPH in community settings.
Study Design: The study is designed as a community-based cluster Randomised Control Trial. The study will enroll women delivering at Primary Health Centres (PHCs). Study centres will be assigned to one of the following: Group 1: 600 mcg oral Misoprostol, Group 2: 10 IU IM Oxytocin delivered by Uniject®.
Study Procedures
- Informed consent /Enrollment: Women will be approached by trained study staff in the third trimester or when they present for delivery and asked if they wish to participate in the study. Women who meet the study's eligibility criteria and agree to participate will be asked to provide written consent. After enrollment, their baseline data will be recorded and a pre-delivery hemoglobin assessment will be done.
- At time of delivery: Standard procedures to manage the delivery will be followed. Immediately after delivery, participants will be given the assigned study medication (either Misoprostol or Oxytocin by Uniject®). The provider will monitor the women for side effects for 1 - 2 hours after delivery. Referrals will be carried out as per standard of care in each setting and documented.
- After delivery: The follow up visit will be conducted by a trained community health worker. Post-delivery Hb will be recorded for all women approximately 72 hours after delivery. Women's experiences of side effects, and acceptability and satisfaction with her care will be documented.
Study Site and Sample: The study will be conducted in the Jamnagar district in Gujarat,India. Twenty seven PHCs will be considered eligible for participation. To detect a significant difference (pre- to post-delivery Hb) between the two prophylactic regimens of 0.1 g/dL (SD 0.3 g/dL), and also adjusting for the cluster design, a total sample of approximately 1500 deliveries is planned(750 deliveries per group).
Study Medications: Both the drugs and Uniject device will be obtained from a pharmaceutical company in compliance with good manufacturing procedures. Gynuity will be responsible for supplying and re-supplying both the medications throughout the study and will monitor all logistics related to supply.
Ethical considerations: Both the drugs are safe, effective evidence-based prophylactic uterotonics to prevent PPH. However, the protocol will be approved by all relevant Institutional Review Boards prior to enrollment of study participants. Only authorized study personnel will have access to study supplies and documents.
Monitoring and Evaluation: An independent data and safety monitoring board will review the data periodically and make recommendations to investigators concerning study modification, if needed.
Studietype
Fase
- Fase 3
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Pregnant women planning vaginal delivery with a trained study provider at a PHC who are eligible to participate in research according to national guidelines and able to provide informed consent.
Exclusion Criteria:
- Women not delivering in study catchment area with a trained study provider will not be eligible to participate in the trial.
- Women with known contraindications to prostaglandins, including misoprostol will also be excluded.
- Women delivering in a facility that currently routinely administers prophylactic oxytocin to women in the third stage labor will also be excluded.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Group 1
600 mcg oral misoprostol
|
600 mcg oral misoprostol to be administered after delivery of baby and before placenta is expelled
Andere namen:
|
Experimenteel: Group 2
10 IU oxytocin in Uniject
|
10 IU oxytocin in Uniject will be administered after delivery of baby and before placenta is expelled
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Mean change in Pre- and post-delivery Haemoglobin
Tijdsspanne: 18 months
|
To establish the comparable effectiveness of two programmatic strategies, individual pre- and post-delivery Hb measures will be taken to calculate change in Hb.
This will be done using a Hemocue Hemoglobin machine + cuvette (HemoCue, Angelholm, Sweden).
The Hemocue is a simple means of collecting Hb measures at the community-level where traditional laboratory techniques are not feasible.
|
18 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Safety
Tijdsspanne: 18 months
|
Occurrence and management of side effects, timing of drug administration and serious adverse outcomes
|
18 months
|
Clinical effectiveness
Tijdsspanne: 18 months
|
Change in hemoglobin ≥ 2 g/dL, prolonged third stage of labor, any additional interventions carried out.
|
18 months
|
Programmatic feasibility
Tijdsspanne: 18 months
|
Acceptability among women and providers,drug accountability, disposal and management, any problems to report, refusals or complaints by women or their families
|
18 months
|
Cost-effectiveness
Tijdsspanne: 18 months
|
Costs of supplies, wastage, refresher trainings, storage and transportation, referrals and management of side effects will be assessed.
|
18 months
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Zwangerschap Complicaties
- Verloskundige arbeidscomplicaties
- Puerperale aandoeningen
- Bloeding van de baarmoeder
- Bloeding
- Post-partumbloeding
- Fysiologische effecten van medicijnen
- Gastro-intestinale middelen
- Reproductieve controlemiddelen
- Middelen tegen zweren
- Afbrekende middelen, niet-steroïde
- Abortieve agenten
- Oxytocici
- Oxytocine
- Misoprostol
Andere studie-ID-nummers
- 1.3.4
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Post-partumbloeding
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University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development...VoltooidPostpartumVerenigde Staten, Guatemala
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Assistance Publique Hopitaux De MarseilleOnbekend
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Vastra Gotaland RegionVoltooid
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The University of Texas Health Science Center,...VoltooidPostpartum | Physician RoundsVerenigde Staten
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Université de Reims Champagne-ArdenneNog niet aan het werven
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Baylor College of MedicineTexas Department of Family Protective ServicesWerving
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University of PennsylvaniaActief, niet wervend
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Western Kentucky UniversityUniversity of KentuckyVoltooidZwangerschap | PostpartumVerenigde Staten
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Washington University School of MedicineSociety of Family PlanningVoltooidPostpartum-periodeVerenigde Staten
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Nottingham Trent UniversityUniversity of Nottingham; Ministry of Defence, United Kingdom; University of Stirling en andere medewerkersWervingPostpartum-periodeVerenigd Koninkrijk
Klinische onderzoeken op Misoprostol
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Hospital de Clinicas de Porto AlegreVoltooidMiskraam in het eerste trimesterBrazilië
-
Ferring PharmaceuticalsVoltooidCervicale rijping | ArbeidsinductieVerenigd Koninkrijk
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Karolinska InstitutetVoltooidZwangerschap in het eerste trimester | Chirurgische beëindiging van de zwangerschapZweden
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CHA UniversityVoltooid
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Wenzhou Medical UniversityOnbekend
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University of Texas Southwestern Medical CenterVoltooidZwangerschap | Arbeid, geïnduceerdVerenigde Staten
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Universidad de la RepublicaVoltooid
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Cairo UniversityNog niet aan het wervenZwangerschap | Werk | Misoprostol | Nullipaar
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Assiut UniversityVoltooidBloeden tijdens myomectomieEgypte
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Cairo UniversityVoltooid