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

NCT06841939 | Completed

• 1 other identifier: AEFUTHA/REC/VOL.3/2020/015
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Castor Oil; Prolonged Pregnancy

Keywords

Castor oil; Induction of labour; Prolonged pregnancy

Outcome Measures

Primary Outcomes (1)

• formal Induction of labour

  proportion of women who had formal induction of labour

  24 hours

Study Arms (2)

Castor oil

EXPERIMENTAL

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

Water

PLACEBO COMPARATOR

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

Interventions

castor oil OTHER

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.

Castor oil

Water OTHER

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.

Water

Eligibility Criteria

• Age: 20 Years - 44 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Pregnant women in latent phase of labour
• Preterm or term premature rupture of membrane
• Antepartum haemorrhage
• Previous Caesarean section and myomectomy
• Multiple gestation
• Medical disorders of pregnancy
• Unsure date

Sponsors & Collaborators

• Assumpta Nnenna Nweke: lead

Study Sites (1)

Alex Ekwueme Federal University Teaching Hospital

Abakaliki, Ebonyi State, 480101, Nigeria

Location

MeSH Terms

Conditions

Pregnancy, Prolonged

Interventions

Castor Oil; Water

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Assumpta N Nweke, MBBSMBBS

  Alex Ekwueme Federal University Teaching Hospital Abakaliki Ebonyi State

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: open label clinical superiority randomized controlled trial

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 24, 2025
• Study Start: March 5, 2021
• Primary Completion: January 4, 2022
• Study Completion: January 4, 2022
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)