Comparison between active management and conservative management of term nulliparas with prolonged latent phase.

Not Applicable

Completed

• Conditions: Prolonged latent phase or the best management for it.; Pregnancy and Childbirth

• Registration Number: ISRCTN14099170
• Lead Sponsor: niversity Malaya Medical Center

Brief Summary

2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31829138 (added 13/05/2020)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-05
• Study Completion: 2016-05-31
• Last Update Posted: 25 May 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 318

Inclusion Criteria

1. Nulliparous women with singleton fetus in cephalic presentation
2. The gestational age from 39 weeks +0 until 41 completed weeks confirmed by ultrasound performed before 20 weeks period of gestational
3. An overnight admission for latent phase of labor and still having contractions of at least 1:30
4. Cervical dilatation will have to be 3cm and below with intact membranes shortly prior to the participation
5. Reassuring cardiotocogram

Exclusion Criteria

1. Those who do not fulfill the inclusion criteria
2. Those who do not agree to participate in the study
3. There should be no complaints of reduced fetal movements or leaking liqour upon presentation.
4. Patients with hypertensive disease in pregnancy, gestational diabetes and significant maternal disease will be excluded from the study
5. Estimated fetal weight more than 4kg or less than 2kg will not be included in the study
6. No other fetal or maternal indication to expedite delivery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be the mode of delivery (caesarean section or vaginal delivery)

Secondary Outcome Measures

Name	Time	Method
<br> 1. Duration of labor (from participation to active phase and to second stage of labour)<br> 2. Initial Bishop score and VAS score upon admission<br> 3. Any analgesia needed during the latent phase<br> 4. Any intrapartum exogenous oxytocin stimulation during labor<br> 5. Any hyperstimulation<br> 6. Postpartum hemorrhage<br> 7. Patient's satisfaction score and neonatal outcomes<br><br> Patient's score will be given according to the Likert scale based on a few statements regarding their experience during the study.<br><br> Neonatal outcomes:<br> 1. 5-min Apgar score below 7<br> 2. Cord artery metabolic acidosis (pH = 7 and BE = 12)<br> 3. Birthweight<br> 4. Any admission to the neonatal intensive care unit (NICU) immediately after delivery<br>