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

NCT ID: NCT06841939

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-05
• Study Completion Date: 2022-01-04

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.

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.

Conditions

Castor Oil; Prolonged Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

castor oil

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Water

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assumpta Nnenna Nweke

OTHER_GOV

Sponsor Role: lead

Responsible Party

Assumpta Nnenna Nweke

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Assumpta N Nweke, MBBSMBBS

Role: PRINCIPAL_INVESTIGATOR

Alex Ekwueme Federal University Teaching Hospital Abakaliki Ebonyi State

Locations

Alex Ekwueme Federal University Teaching Hospital

Abakaliki, Ebonyi State, Nigeria

Countries

Nigeria

Other Identifiers

AEFUTHA/REC/VOL.3/2020/015

Identifier Type: -

Identifier Source: org_study_id