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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02695238 |
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Date of registration:
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29/01/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
PROPOP |
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Scientific title:
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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 |
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Date of first enrolment:
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December 2015 |
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Target sample size:
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260 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02695238 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Urielle Desalbres |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique Hopitaux De Marseille |
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Name:
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Julie Blanc |
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Address:
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Telephone:
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Email:
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julie.blanc@ap-hm.fr |
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Affiliation:
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Name:
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Julie Blanc, MD |
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Address:
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Telephone:
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Email:
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julie.blanc@ap-hm.fr |
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Affiliation:
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Persistent Occipital Posterior Presentation During Labor Delivery
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Intervention(s)
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Procedure: Prophylactic Manual Rotation of persistent occipital posterior presentation
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Primary Outcome(s)
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Number of patients who will have a caesarean section or an instrumental delivery in each groups.
[Time Frame: 4 hours]
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Secondary Outcome(s)
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Number of patients with episiotomy, perineal lacerations from the 1st to the 4rth degree anglo-saxon classification
[Time Frame: 4 hours]
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Number of patients with post-partum hemorrhage defined by blood loss more than 500mL
[Time Frame: 5 hours maximum]
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Number of patients who will have bladder, urinary or bowel injuries during caesarean section
[Time Frame: 5 hours maximum]
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Secondary ID(s)
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2015-A00225-44
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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