Castor OilNCT06841939
Effectiveness of Castor Oil in Preventing Formal Induction of Labour in a Tertiary Institution
A study testing castor oil and Water in people with Castor Oil and Prolonged Pregnancy, run by Assumpta Nnenna Nweke at 1 site in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Castor Oil, Prolonged Pregnancy
- What is being tested?
- castor oil and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteNigeria
- Study dates
- 5 Mar 2021to 4 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Nigeria1 site
Alex Ekwueme Federal University Teaching Hospital
Abakaliki, Ebonyi State, 480101
About this study
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.
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.
Read the 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
- Being tested
- castor oil, Water
- Keywords
- Castor oil, Induction of labour, Prolonged pregnancy
- Medical subject headings
- Pregnancy, Prolonged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
castor oilOther
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.
WaterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
formal Induction of labour
proportion of women who had formal induction of labour
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start5 Mar 2021
- Primary completion4 Jan 2022
- Study completion4 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castor OilStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open label clinical superiority randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assumpta Nnenna Nweke
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Assumpta Nnenna Nweke, Federal Teaching Hospital Abakaliki
- Investigators
- Assumpta N Nweke, MBBSMBBS, Principal investigator, Alex Ekwueme Federal University Teaching Hospital Abakaliki Ebonyi State
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841939
- Sponsor's protocol ID
- AEFUTHA/REC/VOL.3/2020/015
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06841939
- Acronym / sponsor ID
- AEFUTHA/REC/VOL.3/2020/015
- Conditions
- Castor Oil, Prolonged Pregnancy
- Keywords
- Castor oil, Induction of labour, Prolonged pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assumpta Nnenna NwekeOther government
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 4 Jan 2022 (actual)
- Study completion
- 4 Jan 2022 (actual)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open label clinical superiority randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Castor oil | Experimental | Other: castor oilParticipants 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 | Placebo comparator | Other: WaterParticipants 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. |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- Pregnant women in latent phase of labour
- Preterm or term premature rupture of membrane
- Antepartum haemorrhage
- Previous Caesarean section and myomectomy
- Multiple gestation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| castor oilParticipants 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 |
| WaterParticipants 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 |
Primary outcome
formal Induction of labour
Time frame: 24 hours
proportion of women who had formal induction of labour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Assumpta N Nweke, MBBSMBBS principal investigator
Alex Ekwueme Federal University Teaching Hospital Abakaliki Ebonyi State
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing castor oil and Water in people with Castor Oil and Prolonged Pregnancy, run by Assumpta Nnenna Nweke at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
formal Induction of labour (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.