Effect of early and late amniotomy on caesarean section rate and duration of first stage of labor in low-risk pregnancy: A randomized control trial

Phase 3

Completed

• Conditions: amniotomy; early Vs late amniotomy in low-risk term pregnancy group to caesarean section rate, duration of first stage of labor, maternal outcomes and neonatal outcomes; caesarean section rate; first stage of labor duration

• Registration Number: TCTR20210818004
• Lead Sponsor: /A

Brief Summary

Early amniotomy significantly reduced the duration of the active phase of labor without increasing risk of cesarean section, maternal and neonatal complications.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-18
• Study Completion: 2022-02-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 132

Inclusion Criteria

1. low-risk pregnancy
2. fetal cephalic presentation
3. presenting to labor room with labor pain
4. cervical dilatation 3-5 cm
5. membrane intact

Exclusion Criteria

1. presenting of any contraindication of amniotomy for example placenta previa, vasa previa
2. fetal anomalies or abnormal Quad test with abnormal karyotype
3. A low-risk pregnancy women with external fetal monitoring category II, III
4. antenatal risk such as GDMA2, PIH, HIV infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
caesarean section rate at 26 hours after entering labor room percentage

Secondary Outcome Measures

Name	Time	Method
duration of first stage of labor at the time when neonatal are born duration of latent phase of labor until fully dilatation of cervix,maternal outcomes observe clinical signs of chorioamnionitis during labor time until neonatal are born, observe umbilical prolapse suddenly after performing amniotomy chorioamnionitis, umbilical cord prolapse, postpartum hemorrhage, puerperal infection,neonatal outcomes after neonatal are born and within 72 hours birth body weight, APGAR score, respiratory support, delayed adaptive, transient tachypnea of newborn, NICU admission, neonatal sepsis, neonatal death