- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05333731
Oxytocin Induction in Full Term Pregnant Women With Cesarean Section of Prelabor Rupture of Membranes
April 17, 2022 updated by: The First Affiliated Hospital with Nanjing Medical University
To Study the Effectiveness and Safety of Oxytocin Induction in Full Term Pregnant Women With Cesarean Section of Prelabor Rupture of Membranes: a Multi-center, Prospective, Observational Study
This study is a multi-center, prospective, observational clinical trial study.
528 full-term pregnant women will be enrolled as subjects, and the ratio of eligible subjects in the two groups is 1:1.
In the cesarean section group, full term pregnant women with prelabor rupture of membrane (PROM) who are willing to try the trial of labor after cesarean (TOLAC) and in accordance with the criteria according to the 2016 China vaginal birth after cesarean (VBAC) clinical management guidelines will be enrolled and recorded by our homemade registration form of TOLAC.
In the non-cesarean section group, pregnant women after 37 weeks of gestation with PROM but without vaginal labor contraindications will be enrolled.
Whether in the cesarean section group or non-cesarean section group, if spontaneous labor does not occur, and they all will be induced by oxytocin.
After 24 hours, their final delivery mode will be recorded.
In the following 42 days postpartum, their complications and the neonatal outcome will be followed up.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
528
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
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Nanjing, Jiangsu, China
- Recruiting
- First Affiliated Hospital of Nanjing Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 38 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
In the cesarean section group, the extra inclusion criteria includes:
Only one prior low transverse uterine incision;
Extra exclusion criteria:
- With mutiple history of c esction;
- Prior extensive transfundal uterine surgery, such as for fetal surgery, myomectomy, or uterine reconstruction; Prior classical vertical uterine incision, or an inverted "T" or "J" incision;
- Short interpregnancy interval;
- Prior uterine rupture or dehiscence, or cesarean scar pregnancy;
- Evaluated fetal birth weight> 4000 g.
In the non-cesarean section group, the extra criteria should include:
nulliparous
Description
Inclusion Criteria:
- Volunteers sign the informed consent;
- Age: 20-40 years;
- Singleton, a cephalic presentation;
- No contradiction to vaginal delivery;
- gestation: 37~42 weeks;
- With prelabor rupture of membrane.
Exclusion criteria:
- Konwn contraindication to vaginal delivery or severe complications;
- Multiple gestation;
- Uterine malformation;
- Severe psychiatric disorder;
- Without family's support.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cesarean section group
In the cesarean section group, all the pregnant women had only one prior cesarean section.
|
In the two groups, if spontaneous labor does not occur after PROM, they all receive the oxytocin for up to 24h.
|
Non-cesarean section group
In the non-cesarean section group, all the pregnant women are primipara, and never had a cesarean section.
|
In the two groups, if spontaneous labor does not occur after PROM, they all receive the oxytocin for up to 24h.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vignial birth rate
Time Frame: 24 hours
|
After the treatment of oxytocin induction for up tp 24 hours, the mode of delivery will be konwn and recorded.
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Prelabor Rupture of Membranes: ACOG Practice Bulletin, Number 217. Obstet Gynecol. 2020 Mar;135(3):e80-e97. doi: 10.1097/AOG.0000000000003700.
- Bellussi F, Livi A, Diglio J, Lenzi J, Magnani L, Pilu G. Timing of induction for term prelabor rupture of membranes and intravenous antibiotics. Am J Obstet Gynecol MFM. 2021 Jan;3(1):100245. doi: 10.1016/j.ajogmf.2020.100245. Epub 2020 Oct 6.
- Fishel Bartal M, Sibai BM, Ilan H, Fried M, Rahav R, Alexandroni H, Schushan Eisan I, Hendler I. Trial of labor after cesarean (TOLAC) in women with premature rupture of membranes(). J Matern Fetal Neonatal Med. 2020 Sep;33(17):2976-2982. doi: 10.1080/14767058.2019.1566312. Epub 2019 Jan 17.
- Middleton P, Shepherd E, Flenady V, McBain RD, Crowther CA. Planned early birth versus expectant management (waiting) for prelabour rupture of membranes at term (37 weeks or more). Cochrane Database Syst Rev. 2017 Jan 4;1(1):CD005302. doi: 10.1002/14651858.CD005302.pub3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 30, 2022
Primary Completion (Anticipated)
December 30, 2024
Study Completion (Anticipated)
June 30, 2025
Study Registration Dates
First Submitted
February 8, 2022
First Submitted That Met QC Criteria
April 17, 2022
First Posted (Actual)
April 19, 2022
Study Record Updates
Last Update Posted (Actual)
April 19, 2022
Last Update Submitted That Met QC Criteria
April 17, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JPPTOLAC-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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