Persistent Occipital Posterior Presentation During Labor DeliveryPROPOPNCT02695238
Trial of Prophylactic Manual Rotation of Persistent Occiput Posterior Presentation During the Early Second Stage of Labor to Reduce Operative Delivery: a Prospective Multicenter Randomized Control Trial
A study testing Prophylactic Manual Rotation of persistent occipital posterior presentation in people with Persistent Occipital Posterior Presentation During Labor Delivery, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Superiority multicenter prospective randomized study on operative delivery (instrumental delivery or caesarean section) of prophylactic manual rotation in case of persistent occipital posterior presentation during the second stage of labor compared to expectant management. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Persistent Occipital Posterior Presentation During Labor Delivery
- What is being tested?
- Prophylactic Manual Rotation of persistent occipital posterior presentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to Jun 2020
- Phase
- Interventional
- 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
- Age ≥ 18 years
- Singleton pregnancy
- Term ≥ 37 weeks of gestation
- Early second stage of labor
- Rupture membranes
- Persistent occiput posterior position confirmed by ultrasound
- Epidural anesthesia
- Patient who agree to participate and sign consent form
Who cannot join
- Age < 18 years
- Term < 37 weeks of gestation
- Vaginal and instrumental Delivery maternal contraindication
- Antecedent of perineal injury type IV
- Sensitive perineum
- Crohn's disease with vaginal delivery contraindication
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- Instrumental fetal contraindication
- Non reassuring fetal heart with impossibility of optimal maternal information
- Known fetal malformation
- Previous ceaserean section
- Non cephalic presentation
- Not affiliated to social security
Trial locations and contacts
1 site in 1 country.
Julie Blanc, MD contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, 13354
Julie Blanc, julie.blanc@ap-hm.fr
About this study
Superiority multicenter prospective randomized study on operative delivery (instrumental delivery or caesarean section) of prophylactic manual rotation in case of persistent occipital posterior presentation during the second stage of labor compared to expectant management. A 15% reduction of operative delivery (instrumental delivery or caesarean section) is attempt in the prophylactic manual rotation group.
- Being tested
- Prophylactic Manual Rotation of persistent occipital posterior presentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic Manual Rotation of persistent occipital posterior presentationProcedure or surgery
prophylactic manual rotation of persistent occipital posterior presentation on operative delivery will be performed in the experimental group
| Study group | Role | What they receive |
|---|---|---|
| prophylactic manual rotation group | Experimental | During persistent occipital posterior presentation during the second stage of labor, prophylactic manual rotation will be performed. Receives: Procedure: Prophylactic Manual Rotation of persistent occipital posterior presentation |
| No prophylactic manual rotation group | No intervention | During persistent occipital posterior presentation during the second stage of labor, expectant management for delevery will be performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who will have a caesarean section or an instrumental delivery in each groups.
Measured: 4 hours
Secondary outcomes (3)
Number of patients with episiotomy, perineal lacerations from the 1st to the 4rth degree anglo-saxon classification
Measured: 4 hours
Number of patients who will have bladder, urinary or bowel injuries during caesarean section
Measured: 5 hours maximum
Number of patients with post-partum hemorrhage defined by blood loss more than 500mL
Measured: 5 hours maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent Occipital Posterior Presentation During Labor DeliveryStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle Desalbres, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695238
- Sponsor's protocol ID
- 2015-A00225-44
- Acronym
- PROPOP
- Status last verified
- Jul 2019
- First submitted
- 29 Jan 2016
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Blanc J, Castel P, Mauviel F, Baumstarck K, Bretelle F, D'Ercole C, Haumonte JB. Prophylactic manual rotation of occiput posterior and transverse positions to decrease operative delivery: the PROPOP randomized clinical trial. Am J Obstet Gynecol. 2021 Oct;225(4):444.e1-444.e8. doi: 10.1016/j.ajog.2021.05.020. Epub 2021 May 24.
PubMed 34033811
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Prophylactic Manual Rotation of Persistent Occiput Posterior Presentation During the Early Second Stage of Labor to Reduce Operative Delivery: a Prospective Multicenter Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02695238
- Acronym / sponsor ID
- PROPOP / 2015-A00225-44
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 1 Mar 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.
Superiority multicenter prospective randomized study on operative delivery (instrumental delivery or caesarean section) of prophylactic manual rotation in case of persistent occipital posterior presentation during the second stage of labor compared to expectant management. A 15% reduction of operative delivery (instrumental delivery or caesarean section) is attempt in the prophylactic manual rotation group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prophylactic manual rotation group | Experimental | Procedure: Prophylactic Manual Rotation of persistent occipital posterior presentationDuring persistent occipital posterior presentation during the second stage of labor, prophylactic manual rotation will be performed. |
| No prophylactic manual rotation group | No intervention | –During persistent occipital posterior presentation during the second stage of labor, expectant management for delevery will be performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Singleton pregnancy
- Term ≥ 37 weeks of gestation
- Early second stage of labor
- Rupture membranes
Key exclusion criteria (12 listed)
- Age < 18 years
- Term < 37 weeks of gestation
- Vaginal and instrumental Delivery maternal contraindication
- Antecedent of perineal injury type IV
- Sensitive perineum
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 |
|---|---|---|
| Prophylactic Manual Rotation of persistent occipital posterior presentationprophylactic manual rotation of persistent occipital posterior presentation on operative delivery will be performed in the experimental group | Procedure or surgery | prophylactic manual rotation group |
Primary outcome
Number of patients who will have a caesarean section or an instrumental delivery in each groups.
Time frame: 4 hours
3 secondary outcomes
Number of patients with episiotomy, perineal lacerations from the 1st to the 4rth degree anglo-saxon classification
Time frame: 4 hours
Number of patients who will have bladder, urinary or bowel injuries during caesarean section
Time frame: 5 hours maximum
Number of patients with post-partum hemorrhage defined by blood loss more than 500mL
Time frame: 5 hours maximum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Derived from this study: PubMed 34033811Blanc J, Castel P, Mauviel F, Baumstarck K, Bretelle F, D'Ercole C, Haumonte JB. Prophylactic manual rotation of occiput posterior and transverse positions to decrease operative delivery: the PROPOP randomized clinical trial. Am J Obstet Gynecol. 2021 Oct;225(4):444.e1-444.e8. doi: 10.1016/j.ajog.2021.05.020. Epub 2021 May 24.
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.
Julie Blanc, MD contact
Urielle Desalbres study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic Manual Rotation of persistent occipital posterior presentation in people with Persistent Occipital Posterior Presentation During Labor Delivery, run by Assistance Publique Hopitaux De Marseille 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 8 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 19 Jul 2019. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Blanc, MD (julie.blanc@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who will have a caesarean section or an instrumental delivery in each groups. (time frame: 4 hours). 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 NCT02695238, which also lists 1 linked publication.
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 19 Jul 2019.