MedDataX Logo

Castror Oil for Labor Induction in Women With Previous Cesarean Section

NCT ID: NCT03958981

Last Updated: 2021-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-15

Study Completion Date

2020-07-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Induction of Labor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

castor oil group

60 mL of castor oil in 140 mL of orange juice

Group Type EXPERIMENTAL

Castor Oil

Intervention Type DRUG

The intervention group will be given 60 mL of castor oil in 140 mL of orange juice

placebo group

Patients will receive sunflower oil as a placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

the control group will be given a sunflower oil as a placebo with a similar texture to castor oil

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Castor Oil

The intervention group will be given 60 mL of castor oil in 140 mL of orange juice

Intervention Type DRUG

placebo

the control group will be given a sunflower oil as a placebo with a similar texture to castor oil

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mohamed El Sharkawy

UNKNOWN

Sponsor Role collaborator

Yomna Bayoumi

UNKNOWN

Sponsor Role collaborator

mohamed hisham gouda

UNKNOWN

Sponsor Role collaborator

Dina latif

UNKNOWN

Sponsor Role collaborator

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahmed Samy aly ashour

assistant professor of obstetrics and gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yomna Bayoumi, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

faculty of medicine Cairo university

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

castor oil

Identifier Type: -

Identifier Source: org_study_id