Clinical trial NCT06841939: Effectiveness of Castor Oil in Preventing Formal Induction of Labour in a Tertiary Institution
Official title: Effectiveness of Castor Oil in Preventing Formal Induction of Labour Among Pregnant Women at a Tertiary Institution in Abakaliki: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Castor Oil
Prolonged Pregnancy
Keywords: Castor oil
Induction of labour
Prolonged pregnancy
Lead sponsor: Federal Teaching Hospital Abakaliki
Sponsor class: OTHER_GOV
First posted: 2025-02-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open label clinical superiority randomized controlled trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: formal Induction of labour
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Abakaliki
country: Nigeria
facility: Alex Ekwueme Federal University Teaching Hospital
state: Ebonyi
Study officials:
affiliation: Alex Ekwueme Federal University Teaching Hospital Abakaliki Ebonyi State
name: Assumpta N Nweke, MBBSMBBS
role: PRINCIPAL_INVESTIGATOR
References: