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

Induction of labour compared to expectant management of term nulliparas with prolonged latent phase: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14099170
Enrollment
300
Registered
2015-11-05
Start date
2015-06-01
Completion date
Unknown
Last updated
2020-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prolonged latent phase or the best management for it. Pregnancy and Childbirth

Interventions

Each woman will be randomly allocated to one of two groups: 1. Early induction group 2. Expectant management group Spontaneous onset of active phase of

Sponsors

University Malaya Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The primary outcome will be the mode of delivery (caesarean section or vaginal delivery)

Secondary

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

Countries

Malaysia

Contacts

Public ContactLindy;Dr Noor Azmi Bak Li Mei;Bin Adenan

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Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 1, 2026