Hemorrhage; Complicating DeliveryPhase 4CYTOCINONNCT01113229
Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage
A Phase 4 study testing Misoprostol in people with Hemorrhage; Complicating Delivery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hemorrhage; Complicating Delivery
- What is being tested?
- Misoprostol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,721 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women>18 years,
- during first stage of normal labor,
- at 36 to 42 weeks,
- with epidural analgesia and informed signed consent
Who cannot join
- Cesarean section delivery,
- clotting disorders,
- prostaglandin allergy,
- absent consent.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Objective :
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
- Hemorrhage; Complicating Delivery
- Being tested
- Misoprostol
- Keywords
- Post Partum Haemorrhage,, oxytocin,, misoprostol,, prevention,, delivery.
- Medical subject headings
- Hemorrhage, Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called two misoprostol tablets taken orally (400µg
two misoprostol tablets taken orally (400µg)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of post partum hemorrhage > 500mL in 1 hour
Measured: 1 HOUR
Secondary outcomes (1)
Occurrence of post partum hemorrhage > 1000mL in 1 hour
Measured: 1 HOUR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2014
- Study completionDec 2014
Why it stopped: reason of halt prematurely: futility of the trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hemorrhage; Complicating DeliveryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,721 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Patrick Rozenberg, MD, Principal investigator, CHI POISSY ST GERMAIN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113229
- Sponsor's protocol ID
- P081104
- Other IDs
- 2009-013177-18, 2009
- Acronym
- CYTOCINON
- Status last verified
- Mar 2026
- First submitted
- 28 Apr 2010
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27607864Voillequin 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.
PubMed 39934771
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage
- ClinicalTrials.gov ID
- NCT01113229
- Acronym / sponsor ID
- CYTOCINON / P081104
- Conditions
- Hemorrhage; Complicating Delivery
- Keywords
- Post Partum Haemorrhage,, oxytocin,, misoprostol,, prevention,, delivery.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: reason of halt prematurely: futility of the trial
- Enrolment
- 1,721 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Mar 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective :
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol | Experimental | Drug: Misoprostol10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and two misoprostol tablets taken orally (400µg) following cord clamp |
| PLACEBO | Placebo comparator | Drug: Misoprostol10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and two placebo tablets taken orally following cord clamp. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women>18 years,
- during first stage of normal labor,
- at 36 to 42 weeks,
- with epidural analgesia and informed signed consent
Key exclusion criteria (4 listed)
- Cesarean section delivery,
- clotting disorders,
- prostaglandin allergy,
- absent consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MisoprostolAlso: two misoprostol tablets taken orally (400µgtwo misoprostol tablets taken orally (400µg) | Drug | Misoprostol, PLACEBO |
Primary outcome
Occurrence of post partum hemorrhage > 500mL in 1 hour
Time frame: 1 HOUR
1 secondary outcome
Occurrence of post partum hemorrhage > 1000mL in 1 hour
Time frame: 1 HOUR
Results and safety
The study was stopped early (reason given: reason of halt prematurely: futility of the trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Results publication: PubMed 27607864Quibel 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.
- Derived from this study: PubMed 39934771Voillequin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Rozenberg, MD principal investigator
CHI POISSY ST GERMAIN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Misoprostol in people with Hemorrhage; Complicating Delivery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: reason of halt prematurely: futility of the trial). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of post partum hemorrhage > 500mL in 1 hour (time frame: 1 HOUR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01113229, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.