Castror Oil for Labor Induction in Women With Previous Cesarean Section
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|ClinicalTrials.gov Identifier: NCT03958981|
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Induction of Labor||Drug: Castor Oil Drug: placebo||Not Applicable|
In cairo university Hospital, castror oil, which is a type of induction methods, is routinely offered to women with previous Caesarean delivery who require induction of labour. However, castor oil may not exert its labour induction effect immediately and the delivery may be delayed by up to 8 days. This may render a proportion of women to resort to repeated Caesarean section for failed induction.Castor oil is traditionally given by midwives in order to induce labor.
The investigators intent to recruit 100 healthy pregnant women with a hsitory of previous cesarean section and with no contraindication to vaginal delivery . Women will be randomly and blindly divided into equal sized intervention group and control group. Intervention group will be given 60 mL of castor oil in 140 mL of orange juice, while control group will be given a placebo with similar texture. Primary outcome to be tested is the percentage of women entering active labor within 24 hours of administration.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Use of Castor Oil for Induction of Labour in Women With Previous Caesarean Delivery: a Randomized Controlled Trial|
|Estimated Study Start Date :||June 15, 2019|
|Estimated Primary Completion Date :||November 1, 2019|
|Estimated Study Completion Date :||November 15, 2019|
Experimental: castor oil group
60 mL of castor oil in 140 mL of orange juice
Drug: Castor Oil
The intervention group will be given 60 mL of castor oil in 140 mL of orange juice
Placebo Comparator: placebo group
Patients will receive sunflower oil as a placebo
the control group will be given a sunflower oil as a placebo with a similar texture to castor oil
- Delivery within 24 hours of administering castor oil/placebo [ Time Frame: two weeks ]Actual time of delivery
- Neonatal apgar scores [ Time Frame: 1 minute and 5 minute after delivery ]Neonatal APGAR scores
- Neonatal complications including hospitalization in NICU [ Time Frame: immediately after birth ]Were there any admissions to NICU, what was the reason ?
- Mode of delivery (ie. Normal delivery Vs. Cesarean delivery) [ Time Frame: Within two weeks of enrollment ]Mode of delivery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958981
|Contact: AHMED SAMY, MDfirstname.lastname@example.org|
|Principal Investigator:||AHMED SAMY||Cairo University|