Best Partograph Action Line to Prevent Prolonged Labour

NCT02911272 | Completed

• 1 other identifier: UBenin
• Study Type: interventional
• Target: 640
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective: To compare active labour outcomes in nulliparous women at term supervised with a partograph with the action line placed at either 2 hours or 4 hours and to determine whether the 2-hour action line placement is better for the prevention of prolonged labour. Design: Randomised controlled trial. Setting: A university teaching hospital in Nigeria. Population: Nulliparous women in labour at term. Method: Nulliparous women in labour were randomly supervised with a partograph with the action line placed at 2 hours (n=320) or 4 hours (n=320). Oxytocin augmentation, when required, was used only at the 2-hour (n=87) or 4-hour (n=61) action lines. Progress monitoring was the same in both groups. Main outcome measure: The primary outcome measure was the prolonged labour rate. The secondary outcome measures were the mode of delivery and neonatal outcome.

Conditions

Prolonged First Stage Labor - Prevention

Keywords

Partograph; Best action line; Prolonged labour prevention

Outcome Measures

Primary Outcomes (1)

• Duration of active phase labour

  Time spent from admission in active phase labour till point of delivery expressed in hours

  At the point of each patient's delivery within 24 hours from onset of labour

Secondary Outcomes (2)

• Mode of delivery

  within 24 hours from onset of labour

• Neonatal Asphyxia

  at the point of delivery within 24 hours from onset of labour

Study Arms (2)

2-hour group

ACTIVE COMPARATOR

Augmentation of labour at 2-hour action line on the labour partograph

Device: 2-hour action line on WHO modified partograph; Drug: Oxytocin; Procedure: Forewater amniotomy

4-hour group

EXPERIMENTAL

Augmentation of labour at 4-hour action line on the labour partograph

Drug: Oxytocin; Procedure: Forewater amniotomy; Device: 4-hour action line on WHO modified partograph

Interventions

2-hour action line on WHO modified partograph DEVICE

observations and findings in a woman in labour are recorded on this device (WHO modified partograph) in a graphic format in which the action line is located 2-hour from the alert line

2-hour group

Oxytocin DRUG

Oxytocin augmentation of slow labour progress at the respective action line location on the WHO modified partograph

2-hour group; 4-hour group

Forewater amniotomy PROCEDURE

Forewater amniotomy at the vaginal examination confirming active phase labour

Also known as: Artificial rupture of membrane

2-hour group; 4-hour group

4-hour action line on WHO modified partograph DEVICE

observations and findings in a woman in labour are recorded on this device (WHO modified partograph) in a graphic format in which the action line is located 4-hour from the alert line

4-hour group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy nulliparous patients at term in spontaneous active phase labour with singleton pregnancies and intact fetal membranes at first vaginal examination in labour ward

You may not qualify if:

• Multiparous patients
• Multiple pregnancies
• Pre-existing medical conditions complicating pregnancy
• Non-cephalic presenting fetus at term
• Prelabour rupture of membrane at term
• Preterm labour
• Poor fetal growth in pregnancy

Sponsors & Collaborators

• University of Benin: lead

Related Publications (1)

• Orhue A, Oseihie II, Aziken M, Ande B. Randomized controlled trial of labor outcomes with action line placement at 2 hours versus 4 hours on the partograph. Int J Gynaecol Obstet. 2020 Jul;150(1):64-71. doi: 10.1002/ijgo.13144. Epub 2020 Apr 17.

  PMID: 32301113 DERIVED

MeSH Terms

Interventions

Oxytocin; Amniotomy

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Labor, Induced; Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Augustine AE Orhue, FRCOG

  University of Benin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 22, 2016
• Study Start: April 1, 2008
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: September 22, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share