Retained PlacentaPhase 4ANDDROIDNCT02969447
Management of Third-stage of Labor After Second Trimester Medical Pregnancy Termination
A Phase 4 study testing Administration of 10 units of intra venous oxytocin after fetal expulsion in people with Retained Placenta, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Prospective randomized trail which compare 2 regimens for third-stage management after second trimester medical pregnancy termination : 10UI intra venous oxytocin or no additional medication after fetal expulsion. Primary outcome was the incidence of placental retention. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Retained Placenta
- What is being tested?
- Administration of 10 units of intra venous oxytocin after fetal expulsion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2016to 4 Aug 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old and older
- medical pregnancy termination between 14 and 28 weeks gestation
- informed consent obtained
Who cannot join
- less than 18 years old
- refusal to consent
- in utero fetal death
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intra-venous Oxytocin Injection After Fetal Expulsion in Management of Third-stage of Labor After Second Trimester Medical Pregnancy Termination
Prospective randomized trail which compare 2 regimens for third-stage management after second trimester medical pregnancy termination : 10UI intra venous oxytocin or no additional medication after fetal expulsion. Primary outcome was the incidence of placental retention.
Read the detailed description
Complication of third stage of labor in second trimester medical pregnancy termination is not well studied. Accord to publications, the placental retention rate is 30 to 40% in these situations. Placental retention may be associated with increased blood loss, increased requirement for blood transfusion anesthetic and operative complications, and infectious morbidity. The high incidence of retained placenta is an area of clinical concern. Publications reveal a wide variation in practices but there are only few studies about third stage of labor in second trimester medical pregnancy termination. The study is a prospective randomized trial. Two third stage management strategies are compared: 10 units of intra venous oxytocin (group 1) and no additional medication (group 2) after fetal expulsion. It concerns pregnancies between 14 and 28 weeks gestation.
- Conditions
- Retained Placenta
- Being tested
- Administration of 10 units of intra venous oxytocin after fetal expulsion
- Keywords
- Retained Placenta, Second trimester medical termination, Third stage labor, Oxytocin
- Medical subject headings
- Placenta, Retained
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of 10 units of intra venous oxytocin after fetal expulsionDrug
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin administration after fetal expulsion | Experimental | Administration of 10 units of intra venous oxytocin after fetal expulsion Receives: Drug: Administration of 10 units of intra venous oxytocin after fetal expulsion |
| No additional medication after fetal expulsion | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of placental retention
Measured: Up to 30 minutes after fetal expulsion
Secondary outcomes (5)
Incidence of partial placental retention
Measured: Up to 1 hour after fetal expulsion
Incidence of digital exploration
Measured: Up to 1 hour after fetal expulsion
Incidence of blunt curettage
Measured: Up to 1 hour after fetal expulsion
Incidence of post-partum hemorrhage
Measured: Up to 1 hour after fetal expulsion
Blood loss
Measured: Up to 1 hour after fetal expulsion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study start20 Oct 2016
- Primary completion4 Aug 2017
- Study completion4 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retained PlacentaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969447
- Sponsor's protocol ID
- CHUBX 2016/20
- Other IDs
- 2016-003143-11, 2016
- Acronym
- ANDDROID
- Status last verified
- Oct 2017
- First submitted
- 17 Nov 2016
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intra-venous Oxytocin Injection After Fetal Expulsion in Management of Third-stage of Labor After Second Trimester Medical Pregnancy Termination
- ClinicalTrials.gov ID
- NCT02969447
- Acronym / sponsor ID
- ANDDROID / CHUBX 2016/20
- Conditions
- Retained Placenta
- Keywords
- Retained Placenta, Second trimester medical termination, Third stage labor, Oxytocin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 20 Oct 2016 (actual)
- Primary completion
- 4 Aug 2017 (actual)
- Study completion
- 4 Aug 2017 (actual)
- First posted
- 21 Nov 2016 (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.
Prospective randomized trail which compare 2 regimens for third-stage management after second trimester medical pregnancy termination : 10UI intra venous oxytocin or no additional medication after fetal expulsion. Primary outcome was the incidence of placental retention.
Detailed description
Complication of third stage of labor in second trimester medical pregnancy termination is not well studied. Accord to publications, the placental retention rate is 30 to 40% in these situations. Placental retention may be associated with increased blood loss, increased requirement for blood transfusion anesthetic and operative complications, and infectious morbidity. The high incidence of retained placenta is an area of clinical concern. Publications reveal a wide variation in practices but there are only few studies about third stage of labor in second trimester medical pregnancy termination. The study is a prospective randomized trial. Two third stage management strategies are compared: 10 units of intra venous oxytocin (group 1) and no additional medication (group 2) after fetal expulsion. It concerns pregnancies between 14 and 28 weeks gestation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin administration after fetal expulsion | Experimental | Drug: Administration of 10 units of intra venous oxytocin after fetal expulsionAdministration of 10 units of intra venous oxytocin after fetal expulsion |
| No additional medication after fetal expulsion | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old and older
- medical pregnancy termination between 14 and 28 weeks gestation
- informed consent obtained
Key exclusion criteria (3 listed)
- less than 18 years old
- refusal to consent
- in utero fetal death
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 |
|---|---|---|
| Administration of 10 units of intra venous oxytocin after fetal expulsion | Drug | Oxytocin administration after fetal expulsion |
Primary outcome
Incidence of placental retention
Time frame: Up to 30 minutes after fetal expulsion
5 secondary outcomes
Incidence of partial placental retention
Time frame: Up to 1 hour after fetal expulsion
Incidence of digital exploration
Time frame: Up to 1 hour after fetal expulsion
Incidence of blunt curettage
Time frame: Up to 1 hour after fetal expulsion
Incidence of post-partum hemorrhage
Time frame: Up to 1 hour after fetal expulsion
Blood loss
Time frame: Up to 1 hour after fetal expulsion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Retained Placenta
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Retained Products of Conception, Hysteroscopy
Recruiting
Removal of Intrauterine Retained Products of Conception (RPOC) After Miscarriage Guided by Hysteroscopy Trial. A Randomized Controlled Trial.
Retained Products of Conception
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Administration of 10 units of intra venous oxytocin after fetal expulsion in people with Retained Placenta, run by University Hospital, Bordeaux 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 12 May 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of placental retention (time frame: Up to 30 minutes after fetal expulsion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2026.