Evaluating labor outcomes in full-term pregnant women with a history of cesarean section
To Study the Effectiveness and Safety of the Trail of Labor in Full Term Pregnant Women With Cesarean Section After Spontaneous Labor: a Multi-center, Prospective, Observational Study
This study is testing if women who had a cesarean section can safely try for a vaginal delivery during their next full-term pregnancy and what the outcomes are.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 510 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT05215041 on ClinicalTrials.gov |
What this trial studies
This observational clinical trial aims to assess the effectiveness and safety of a trial of labor after cesarean (TOLAC) in full-term pregnant women. A total of 510 participants will be enrolled, with half having a prior cesarean section and willing to attempt vaginal delivery, while the other half will consist of women in spontaneous labor without contraindications. The study will track delivery outcomes and any complications for 42 days postpartum. Data will be collected using a custom registration form based on established clinical guidelines.
Who should consider this trial
Good fit: Ideal candidates are full-term pregnant women aged 20-40 with a singleton, cephalic presentation who are in spontaneous labor and have no contraindications to vaginal delivery.
Not a fit: Patients with known contraindications to vaginal delivery, multiple gestations, or severe complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of TOLAC, potentially improving delivery options for women with a history of cesarean sections.
How similar studies have performed: Previous studies have shown varying success rates for TOLAC, indicating that this approach is both relevant and necessary for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Volunteers sign the informed consent 2. Age: 20-40 years; 3. Singleton, a cephalic presentation; 4. No contradiction to vaginal delivery; 5.39\~42 weeks; 6.Spontaneous labor Exclusion criteria: 1. Konwn contraindication to vaginal delivery or severe complications; 2. Multiple gestation; 3. Uterine malformation; 4. Severe psychiatric disorder; 5. Without family's support.
Where this trial is running
Nanjing, Jiangsu
- First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Jiang Ziyan, Ph.D — Department of Obstetrics and Gynecology, First Affiliated Hospital of Nanjing Medical University
- Study coordinator: Jiang Ziyan, Ph.D
- Email: zyjiangchm@163.com
- Phone: 13512534017
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.