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Completed

NCT Number: NCT03958981

Castror Oil for Labor Induction in Women With Previous Cesarean Section

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.

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Key information

Conditions

Induction of Labor

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

faculty of medicine Cairo university

Cairo, 11562, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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

Treatment and study plan

Castor Oil

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Percentage of women entering active phase within 24 hours of administering castor oil/placebo

    Time frame: two weeks

    Actual time of delivery

  2. number of successful VBAC cases

    Time frame: 24 hours

    number of successful cases who delivered vaginally

Secondary outcomes

  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

  4. duration of labor

    Time frame: 24 hours

    duration of labor in hours

  5. number of cases needing oxytocin augmentation

    Time frame: 24 hours

    number of cases needing oxytocin augmentation

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Dina latif
  • Mohamed El Sharkawy
  • Yomna Bayoumi
  • mohamed hisham gouda

Registry information

Official study title

The Use of Castor Oil for Induction of Labour in Women With Previous Caesarean Delivery: a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 22, 2019
Registry last updated
Dec 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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