Effectiveness of Castor Oil in Preventing Formal Induction of Labour in a Tertiary Institution

February 18, 2025 updated by: Assumpta Nnenna Nweke

Effectiveness of Castor Oil in Preventing Formal Induction of Labour Among Pregnant Women at a Tertiary Institution in Abakaliki: A Randomized Controlled Trial.

This study demonstrated that castor oil was effective in reducing the need for formal induction of labour and the administration-delivery interval with minimal maternal side-effects, at an initial dose of 30ml and single repeat dose of 30ml.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Pregnancy extending beyond 42 week is attended by maternal and perinatal complication including death. It is the commonest reason for induction of labour. Various agents have been used to induce labour but it is not without maternal and fetal side effects. Alternative agents such as castor oil have been widely used in clinical practice for induction of labour without any concrete evidence of effectiveness.

Objective: To evaluate the effectiveness of castor oil in the prevention of formal induction of labour amongst pregnant mothers at Alex Ekwueme Federal University Teaching Hospital Abakaliki as well as to evaluate the possible maternal and fetal/ neonatal effects.

Methods: This was a randomized controlled trial among pregnant women at Alex Ekwueme Federal University Teaching Hospital Abakaliki to verify the effectiveness of castor oil in the prevention of formal induction of labour at gestational ages between 41weeks and 0 days and 41 weeks and 2 days. One arm received 30ml of castor oil (Group A) and the other arm received 30ml of water (Group B). These doses were repeated once more after 24 hours if the patients failed to enter spontaneous labour. The data obtained was analyzed using IBM SPSS software (version 24, Chicago II, USA) and the intention to treat concept. A difference with a P value of ≤ 0.05 was taken to be of statistical significance.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
    • Ebonyi
      • Abakaliki, Ebonyi, Nigeria, 480101
        • Alex Ekwueme Federal University Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Gestational age of 41weeks+0day to 41weeks+2days
  2. Pregnancies with cephalic presenting fetuses
  3. Pregnant women with singleton fetus
  4. Absence of contraindications to vaginal delivery
  5. Absence of uterine contraction
  6. Bishop score ≤ 5
  7. Ultrasound confirmed GA in early pregnancy

Exclusion Criteria:

  1. Pregnant women in latent phase of labour
  2. Preterm or term premature rupture of membrane
  3. Antepartum haemorrhage
  4. Previous Caesarean section and myomectomy
  5. Multiple gestation
  6. Medical disorders of pregnancy
  7. Unsure date

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Castor oil
Participants recruited into this group had vaginal examinations conducted and it was confirmed that they were not in labour, Bishop's score was then documented. They were counselled to take 30 ml of castor oil under direct observation by the researcher and the time and date of administration documented. The participants' phone numbers and addresses were also recorded. Participants who fail to achieve labour within 24 hours had a repeat dose of 30 ml of castor oil.
Other: castor oil
Participants recruited into this group had vaginal examinations conducted and it was confirmed that they were not in labour, Bishop's score was then documented. They were counselled to take 30 ml of castor oil under direct observation by the researcher and the time and date of administration documented. The participants' phone numbers and addresses were also recorded. Participants who fail to achieve labour within 24 hours had a repeat dose of 30 ml of castor oil.
Placebo Comparator: Water
Participants recruited into this group had vaginal examinations conducted and it was confirmed that they were not in labour, Bishop's score was then documented. They were counselled to take 30 ml of water under direct observation by the researcher and the time and date of administration documented. The participants' phone numbers and addresses were also recorded. Participants who fail to achieve labour within 24 hours had a repeat dose of 30 ml of water.
Other: Water
Participants recruited into this group had vaginal examinations conducted and it was confirmed that they were not in labour, Bishop's score was then documented. They were counselled to take 30 ml of water under direct observation by the researcher and the time and date of administration documented. The participants' phone numbers and addresses were also recorded. Participants who fail to achieve labour within 24 hours had a repeat dose of 30 ml of water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
formal Induction of labour
Time Frame: 24 hours
proportion of women who had formal induction of labour
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assumpta Nnenna Nweke

Investigators

  • Principal Investigator: Assumpta N Nweke, MBBSMBBS, Alex Ekwueme Federal University Teaching Hospital Abakaliki Ebonyi State

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2021

Primary Completion (Actual)

January 4, 2022

Study Completion (Actual)

January 4, 2022

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

February 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 18, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEFUTHA/REC/VOL.3/2020/015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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