Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage
NCT ID: NCT01113229
Last Updated: 2015-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE4
1721 participants
INTERVENTIONAL
2010-03-31
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Oxytocin Versus, Sublingual Misoprostol in the Secondary Prevention of Postpartum Hemorrhage After Vaginal Delivery
NCT05077540
Prevention of Postpartum Haemorrhage With Sublingual Misoprostol or Oxytocin
NCT01373359
Sublingual vs Intrauterine MISOPROSTOL Plus Oxytocin Infusion for Prevention of Post-cesarean Hemorrhage in High Risk Pregnant Women: A Double-blind Placebo RCT
NCT04560218
Misoprostol for the Treatment of Postpartum Hemorrhage
NCT00116350
Oral Misoprostol Versus Intravenous Oxytocin in Preventing Blood Loss After Non-scheduled Cesarean Section
NCT00107874
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
To demonstrate that the combined used of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin alone, following vaginal birth at 36 to 42 weeks'.
Method :
Double blinded Randomized controlled trial in two centers over 30 months.
Treatment :
Patients will be randomly allocated into one of the two following group :
Group A : 10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and two misoprostol tablets taken orally (400µg) following cord clamp.
Group B: 10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and two placebo tablets taken orally following cord clamp.
Number of patients:
1550 patients per group (one third reduction of occurrence with alpha and beta set at 0.05 and 0.20 respectively). Patients were included in the study during 48 hours.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Misoprostol
10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and two misoprostol tablets taken orally (400µg) following cord clamp
Misoprostol
two misoprostol tablets taken orally (400µg)
PLACEBO
10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and two placebo tablets taken orally following cord clamp.
Misoprostol
two misoprostol tablets taken orally (400µg)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Misoprostol
two misoprostol tablets taken orally (400µg)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* during first stage of normal labor,
* at 36 to 42 weeks,
* with epidural analgesia and informed signed consent
Exclusion Criteria
* clotting disorders,
* prostaglandin allergy,
* absent consent.
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Patrick Rozenberg, MD
Role: PRINCIPAL_INVESTIGATOR
CHI POISSY ST GERMAIN
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chi Poissy St Germain
Poissy, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Voillequin S, Quibel T, Rozenberg P, Rousseau A. Duration of the second and third stages of labor and risk of postpartum hemorrhage: a cohort study stratified by parity. BMC Pregnancy Childbirth. 2025 Feb 11;25(1):143. doi: 10.1186/s12884-025-07229-4.
Quibel T, Ghout I, Goffinet F, Salomon LJ, Fort J, Javoise S, Bussieres L, Aegerter P, Rozenberg P; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Active Management of the Third Stage of Labor With a Combination of Oxytocin and Misoprostol to Prevent Postpartum Hemorrhage: A Randomized Controlled Trial. Obstet Gynecol. 2016 Oct;128(4):805-11. doi: 10.1097/AOG.0000000000001626.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-013177-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
P 081104
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.