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

NCT ID: NCT02695238

Last Updated: 2019-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2020-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Persistent Occipital Posterior Presentation During Labor Delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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prophylactic manual rotation group

During persistent occipital posterior presentation during the second stage of labor, prophylactic manual rotation will be performed.

Group Type EXPERIMENTAL

Prophylactic Manual Rotation of persistent occipital posterior presentation

Intervention Type PROCEDURE

prophylactic manual rotation of persistent occipital posterior presentation on operative delivery will be performed in the experimental group

No prophylactic manual rotation group

During persistent occipital posterior presentation during the second stage of labor, expectant management for delevery will be performed

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prophylactic Manual Rotation of persistent occipital posterior presentation

prophylactic manual rotation of persistent occipital posterior presentation on operative delivery will be performed in the experimental group

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Urielle Desalbres

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

Locations

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Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Julie Blanc, MD

Role: CONTACT

Facility Contacts

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Julie Blanc

Role: primary

References

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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.

Reference Type DERIVED
PMID: 34033811 (View on PubMed)

Other Identifiers

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2015-A00225-44

Identifier Type: -

Identifier Source: org_study_id

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