Induction of LaborNCT03958981
Castror Oil for Labor Induction in Women With Previous Cesarean Section
A study testing Castor Oil in people with Induction of Labor, run by Cairo University at 1 site in Egypt.
Trial summary
Nowadays, more and more women embark on pregnancy with previous Caesarean scar. One in five pregnancies requires induction of labour. The use of non-pharmacological methods (methods without using medication) has been gaining popularity for women who are not good candidates, such as women with previous Caesarean scar… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induction of Labor
- What is being tested?
- Castor Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2019to 15 Jul 2020
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women with one previous lower segment Caesarean section who are admitted to Cairo University Hospital for induction of labor (IOL) will be recruited. The inclusion criteria are age at least 20 years old, gestational age at recruitment from 36 weeks to 38 weeks ±6 days, gestational age at induction= 39 weeks, singleton pregnancy, reassuring fetal status, and Bishop score ≤ 6.
Who cannot join
- Prior high-risk uterine scar; uterine rupture, classical CS, hysterotomy, or myomectomy
- Short inter-delivery interval (<12 months)
- Complications in the previous CS (e.g. puerperal sepsis)
- Obstetric indication for CS (either elective or emergency):
- Placenta praevia
- Placental abruption
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- Documented evidence of cephalopelvic disproportion
- Fetal macrosomia (estimated fetal weight >4 kg)
- Fetal anomalies interfering with vaginal delivery e.g. hydrocephalus
- Fetal distress or non-reassuring Cardiotocography pattern
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Castor Oil for Induction of Labour in Women With Previous Caesarean Delivery: a Randomized Controlled Trial
Nowadays, more and more women embark on pregnancy with previous Caesarean scar. One in five pregnancies requires induction of labour. The use of non-pharmacological methods (methods without using medication) has been gaining popularity for women who are not good candidates, such as women with previous Caesarean scar, for induction with medications such as prostaglandin. Labour induction with prostaglandin carries a higher risk of uterine rupture and thus it is not routinely offered to women with previous Caesarean delivery in Cairo University Hospital. Non-pharmacological methods of induction of labour appear to be safe in women with previous Caesarean delivery. However, various methods are available and the efficacy among them remain in doubt.
Read the detailed description
In Cairo University Hospital, castor oil, which is a type of induction methods, is routinely offered to women with previous Caesarean delivery who require induction of labor. However, castor oil may not exert its labor induction effect immediately and the delivery may be delayed by up to 8 days. This may render a proportion of women resort to repeated Caesarean section for failed induction. Castor oil is traditionally given by midwives in order to induce labor.
The investigators are intent to recruit 70 healthy pregnant women with a history of previous one cesarean section and with no contraindication to trial of labor after cesarean . Women will be randomly and blindly divided into equal-sized intervention group and control group. Intervention group will be given a single dose 60 mL of castor oil in 140 mL of orange juice, while control group will be given a placebo with similar texture. Primary outcomes to be tested are the percentage of women entering active labor within 24 hours of castor oil or placebo administration and the number of successful vaginal deliveries after cesarean.
- Conditions
- Induction of Labor
- Being tested
- Castor Oil, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Castor OilDrug
The intervention group will be given 60 mL of castor oil in 140 mL of orange juice
placeboDrug
the control group will be given a sunflower oil as a placebo with a similar texture to castor oil
| Study group | Role | What they receive |
|---|---|---|
| castor oil group | Experimental | 60 mL of castor oil in 140 mL of orange juice Receives: Drug: Castor Oil |
| placebo group | Placebo comparator | Patients will receive sunflower oil as a placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of women entering active phase within 24 hours of administering castor oil/placebo
Actual time of delivery
Measured: two weeks
number of successful VBAC cases
number of successful cases who delivered vaginally
Measured: 24 hours
Secondary outcomes (5)
Neonatal apgar scores
Neonatal APGAR scores
Measured: 1 minute and 5 minute after delivery
Neonatal complications including hospitalization in NICU
Were there any admissions to NICU, what was the reason ?
Measured: immediately after birth
Mode of delivery (ie. Normal delivery Vs. Cesarean delivery)
Mode of delivery
Measured: Within two weeks of enrollment
duration of labor
duration of labor in hours
Measured: 24 hours
number of cases needing oxytocin augmentation
number of cases needing oxytocin augmentation
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 posted22 May 2019
- Study start15 Jul 2019
- Primary completion30 May 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of LaborStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Mohamed El Sharkawy, Yomna Bayoumi, mohamed hisham gouda, Dina latif
- Responsible party
- Principal investigator, Ahmed Samy aly ashour, Cairo University
- Investigators
- Yomna Bayoumi, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958981
- Sponsor's protocol ID
- castor oil
- Status last verified
- Nov 2021
- First submitted
- 20 May 2019
- Last updated
- 2 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Castor Oil for Induction of Labour in Women With Previous Caesarean Delivery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03958981
- Acronym / sponsor ID
- castor oil
- Conditions
- Induction of Labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Mohamed El Sharkawy, Yomna Bayoumi, mohamed hisham gouda, Dina latif
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 22 May 2019 (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.
Nowadays, more and more women embark on pregnancy with previous Caesarean scar. One in five pregnancies requires induction of labour. The use of non-pharmacological methods (methods without using medication) has been gaining popularity for women who are not good candidates, such as women with previous Caesarean scar, for induction with medications such as prostaglandin. Labour induction with prostaglandin carries a higher risk of uterine rupture and thus it is not routinely offered to women with previous Caesarean delivery in Cairo University Hospital. Non-pharmacological methods of induction of labour appear to be safe in women with previous Caesarean delivery. However, various methods are available and the efficacy among them remain in doubt.
Detailed description
In Cairo University Hospital, castor oil, which is a type of induction methods, is routinely offered to women with previous Caesarean delivery who require induction of labor. However, castor oil may not exert its labor induction effect immediately and the delivery may be delayed by up to 8 days. This may render a proportion of women resort to repeated Caesarean section for failed induction. Castor oil is traditionally given by midwives in order to induce labor.
The investigators are intent to recruit 70 healthy pregnant women with a history of previous one cesarean section and with no contraindication to trial of labor after cesarean . Women will be randomly and blindly divided into equal-sized intervention group and control group. Intervention group will be given a single dose 60 mL of castor oil in 140 mL of orange juice, while control group will be given a placebo with similar texture. Primary outcomes to be tested are the percentage of women entering active labor within 24 hours of castor oil or placebo administration and the number of successful vaginal deliveries after cesarean.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| castor oil group | Experimental | Drug: Castor Oil60 mL of castor oil in 140 mL of orange juice |
| placebo group | Placebo comparator | Drug: placeboPatients will receive sunflower oil as a placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women with one previous lower segment Caesarean section who are admitted to Cairo University Hospital for induction of labor (IOL) will be recruited. The inclusion criteria are age at least 20 years old, gestational age at recruitment from 36 weeks to 38 weeks ±6 days, gestational age at induction= 39 weeks, singleton pregnancy, reassuring fetal status, and Bishop score ≤ 6.
Key exclusion criteria (10 listed)
- Prior high-risk uterine scar; uterine rupture, classical CS, hysterotomy, or myomectomy
- Short inter-delivery interval (<12 months)
- Complications in the previous CS (e.g. puerperal sepsis)
- Placenta praevia
- Placental abruption
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 OilThe intervention group will be given 60 mL of castor oil in 140 mL of orange juice | Drug | castor oil group |
| placebothe control group will be given a sunflower oil as a placebo with a similar texture to castor oil | Drug | placebo group |
Primary outcome
Percentage of women entering active phase within 24 hours of administering castor oil/placebo
Time frame: two weeks
Actual time of delivery
number of successful VBAC cases
Time frame: 24 hours
number of successful cases who delivered vaginally
5 secondary outcomes
Neonatal apgar scores
Time frame: 1 minute and 5 minute after delivery
Neonatal complications including hospitalization in NICU
Time frame: immediately after birth
Mode of delivery (ie. Normal delivery Vs. Cesarean delivery)
Time frame: Within two weeks of enrollment
duration of labor
Time frame: 24 hours
number of cases needing oxytocin augmentation
Time frame: 24 hours
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 2 Dec 2021.
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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.
Yomna Bayoumi, MD principal investigator
Cairo University
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 in people with Induction of Labor, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 10 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 2 Dec 2021. 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 Egypt. 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?
Percentage of women entering active phase within 24 hours of administering castor oil/placebo (time frame: two weeks). The study lists 2 primary outcomes in all. 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 2 Dec 2021.