Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage

NCT01113229 | Terminated Phase 4

• 2 other identifiers: P0811042009-013177-18
• Study Type: interventional
• Target: 1,721
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemorrhage; Complicating Delivery

Keywords

Post Partum Haemorrhage,; oxytocin,; misoprostol,; prevention,; delivery.

Outcome Measures

Primary Outcomes (1)

• Occurrence of post partum hemorrhage > 500mL in 1 hour

  1 HOUR

Secondary Outcomes (1)

• Occurrence of post partum hemorrhage > 1000mL in 1 hour

  1 HOUR

Study Arms (2)

Misoprostol

EXPERIMENTAL

10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and two misoprostol tablets taken orally (400µg) following cord clamp

Drug: Misoprostol

PLACEBO

PLACEBO COMPARATOR

10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and two placebo tablets taken orally following cord clamp.

Drug: Misoprostol

Interventions

Misoprostol DRUG

two misoprostol tablets taken orally (400µg)

Also known as: two misoprostol tablets taken orally (400µg

Misoprostol; PLACEBO

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women\>18 years,
• during first stage of normal labor,
• at 36 to 42 weeks,
• with epidural analgesia and informed signed consent

You may not qualify if:

• Cesarean section delivery,
• clotting disorders,
• prostaglandin allergy,
• absent consent.

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin: collaborator
• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Chi Poissy St Germain

Poissy, 78300, France

Location

Related Publications (2)

• 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.

  PMID: 27607864 RESULT

• 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.

  PMID: 39934771 DERIVED

MeSH Terms

Conditions

Hemorrhage; Postpartum Hemorrhage

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Patrick Rozenberg, MD

  CHI POISSY ST GERMAIN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2010
• First Posted: April 29, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

FR (1)