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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
Sponsor:
Information provided by (Responsible Party):
Ahmed Samy aly ashour, Cairo University

Brief 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, for an induction with medications such as prostaglandin. Labour induction with prostaglandin carries 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.

Condition or disease Intervention/treatment Phase
Induction of Labor Drug: Castor Oil Drug: placebo Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
Drug Information available for: Castor Oil

Arm Intervention/treatment
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
Drug: placebo
the control group will be given a sunflower oil as a placebo with a similar texture to castor oil




Primary Outcome Measures :
  1. Delivery within 24 hours of administering castor oil/placebo [ Time Frame: two weeks ]
    Actual time of delivery


Secondary Outcome Measures :
  1. Neonatal apgar scores [ Time Frame: 1 minute and 5 minute after delivery ]
    Neonatal APGAR scores

  2. Neonatal complications including hospitalization in NICU [ Time Frame: immediately after birth ]
    Were there any admissions to NICU, what was the reason ?

  3. Mode of delivery (ie. Normal delivery Vs. Cesarean delivery) [ Time Frame: Within two weeks of enrollment ]
    Mode of delivery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women with one previous Caesarean section who are admitted to Cairo University Hospital for induction of labor (IOL) will be recruited. The inclusion criteria are age at least 18 years old, gestational age ≥ 38 weeks, singleton pregnancy, reassuring fetal status and modified Bishop score ≤ 6.

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

Information from the National Library of Medicine

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


Contacts
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Contact: AHMED SAMY, MD +201100681167 ahmedsamy8233@gmail.com

Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: AHMED SAMY Cairo University

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Responsible Party: Ahmed Samy aly ashour, assistant professor of obstetrics and gynecology, Cairo University
ClinicalTrials.gov Identifier: NCT03958981     History of Changes
Other Study ID Numbers: castor oil
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Castor Oil
Cathartics
Gastrointestinal Agents