Oxytocin Induction in Full Term Pregnant Women With Cesarean Section of Prelabor Rupture of Membranes

NCT05333731 | Unknown

• 1 other identifier: JPPTOLAC-02
• Study Type: observational
• Target: 528
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Failed Trial of Labor, Unspecified, With Delivery; Failed VBAC (Vaginal Birth After Caesarean); Prelabor Rupture of Membranes; Failed Induction (of Labor) by Oxytocin

Outcome Measures

Primary Outcomes (1)

• Vignial birth rate

  After the treatment of oxytocin induction for up tp 24 hours, the mode of delivery will be konwn and recorded.

  24 hours

Study Arms (2)

Cesarean section group

In the cesarean section group, all the pregnant women had only one prior cesarean section.

Drug: Oxytocin

Non-cesarean section group

In the non-cesarean section group, all the pregnant women are primipara, and never had a cesarean section.

Drug: Oxytocin

Interventions

Oxytocin DRUG

In the two groups, if spontaneous labor does not occur after PROM, they all receive the oxytocin for up to 24h.

Cesarean section group; Non-cesarean section group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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: 1. With mutiple history of c esction; 2. 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; 3. Short interpregnancy interval; 4. Prior uterine rupture or dehiscence, or cesarean scar pregnancy; 5. Evaluated fetal birth weight\> 4000 g. In the non-cesarean section group, the extra criteria should include: nulliparous

You may qualify if:

• 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.

You may not qualify if:

• Konwn contraindication to vaginal delivery or severe complications;
• Multiple gestation;
• Uterine malformation;
• Severe psychiatric disorder;
• Without family's support.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Related Publications (4)

• Prelabor Rupture of Membranes: ACOG Practice Bulletin, Number 217. Obstet Gynecol. 2020 Mar;135(3):e80-e97. doi: 10.1097/AOG.0000000000003700.

  PMID: 32080050 BACKGROUND

• 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.

  PMID: 33451610 BACKGROUND

• 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.

  PMID: 30652525 BACKGROUND

• 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.

  PMID: 28050900 BACKGROUND

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Jiang Ziyan, Ph.D

CONTACT

13512534017; zyjiangchm@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: April 19, 2022
• Study Start: March 30, 2022
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: April 19, 2022

Record last verified: 2022-04

Locations

CN (1)