Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03958981
Other study ID # castor oil
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 15, 2019
Est. completion date July 15, 2020

Study information

Verified date November 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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, 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date July 15, 2020
Est. primary completion date May 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Castor Oil
The intervention group will be given 60 mL of castor oil in 140 mL of orange juice
placebo
the control group will be given a sunflower oil as a placebo with a similar texture to castor oil

Locations

Country Name City State
Egypt faculty of medicine Cairo university Cairo

Sponsors (5)

Lead Sponsor Collaborator
Cairo University Dina latif, Mohamed El Sharkawy, mohamed hisham gouda, Yomna Bayoumi

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of women entering active phase within 24 hours of administering castor oil/placebo Actual time of delivery two weeks
Primary number of successful VBAC cases number of successful cases who delivered vaginally 24 hours
Secondary Neonatal apgar scores Neonatal APGAR scores 1 minute and 5 minute after delivery
Secondary Neonatal complications including hospitalization in NICU Were there any admissions to NICU, what was the reason ? immediately after birth
Secondary Mode of delivery (ie. Normal delivery Vs. Cesarean delivery) Mode of delivery Within two weeks of enrollment
Secondary duration of labor duration of labor in hours 24 hours
Secondary number of cases needing oxytocin augmentation number of cases needing oxytocin augmentation 24 hours
See also
  Status Clinical Trial Phase
Completed NCT01127581 - Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery Phase 3
Completed NCT01139801 - Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon N/A
Active, not recruiting NCT06324279 - Cervical Sliding Sign to Predict Outcome of Induction of Labor
Recruiting NCT05864326 - Heated Saline in Cervical Balloon for Labor Induction, a RCT N/A
Active, not recruiting NCT06056141 - Induction of Labour at Term With Low Dose Oral Misoprostol Versus a Foley Catheter Phase 4
Completed NCT04529837 - Ultrasound Assessment of DILAPAN-S
Completed NCT02477085 - Methods of Labor Induction and Perinatal Outcomes
Completed NCT02098421 - Foley Labor Induction Trial at Term and in PROM Phase 1
Completed NCT03138252 - Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin Phase 3
Recruiting NCT01720394 - Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert Phase 4
Completed NCT00451308 - Induction of Labor With a Foley Balloon Catheter: Inflation With 30ml Compared to 60ml Phase 4
Not yet recruiting NCT05511727 - Use of Single Versus Double Foley's Catheter in Pre-induction Cervical Ripening N/A
Recruiting NCT02762942 - Comparison of Vaginal Misoprostol Plus Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor Phase 4
Completed NCT01283022 - Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study) Phase 2
Recruiting NCT00684606 - Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor N/A
Recruiting NCT05759364 - The Effect of IV PAPAVERINE 80 mg Prior to Catheter Balloon Insertion on Bishop Score and Pain N/A
Recruiting NCT03854383 - Using Isosorbide Mononitrate in Reducing Time in Induction of Labor in Post Date Women Phase 2
Completed NCT01428037 - Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor Phase 3
Terminated NCT03752073 - Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix N/A
Recruiting NCT03045939 - Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours N/A