PROPOP
Sponsor study identifier
interventional
260
1 country
1
Study Start
December 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2015
Date type not reportedThis date has not been verified as actual or estimated.
January 29, 2016
Actual (reported)March 1, 2016
Actual (reported)December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Number of patients who will have a caesarean section or an instrumental delivery in each groups.
4 hours
Number of patients with episiotomy, perineal lacerations from the 1st to the 4rth degree anglo-saxon classification
4 hours
Number of patients who will have bladder, urinary or bowel injuries during caesarean section
5 hours maximum
Number of patients with post-partum hemorrhage defined by blood loss more than 500mL
5 hours maximum
During persistent occipital posterior presentation during the second stage of labor, prophylactic manual rotation will be performed.
During persistent occipital posterior presentation during the second stage of labor, expectant management for delevery will be performed
prophylactic manual rotation of persistent occipital posterior presentation on operative delivery will be performed in the experimental group
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Assistance Publique Hopitaux de Marseille
Marseille, 13354, France
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.
Urielle Desalbres
Assistance Publique Hopitaux De Marseille
First Submitted
January 29, 2016
First Posted
March 1, 2016
Study Start
December 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2019
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 19, 2019
Record last verified: 2019-07
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Source: ClinicalTrials.gov.
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