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出境医 / 临床实验 / Castror Oil for Labor Induction in Women With Previous Cesarean Section

Castror Oil for Labor Induction in Women With Previous Cesarean Section

Study Description
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 80 healthy pregnant women with a hsitory 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 delivaries after cesarean.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 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
Actual Study Start Date : July 15, 2019
Actual Primary Completion Date : May 30, 2020
Actual Study Completion Date : July 15, 2020
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  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 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

  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 18 years old, gestational age ≥ 39 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
Contacts and Locations

Locations
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Egypt
faculty of medicine Cairo university
Cairo, Egypt, 11562
Sponsors and Collaborators
Cairo University
Mohamed El Sharkawy
Yomna Bayoumi
mohamed hisham gouda
Dina latif
Investigators
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Principal Investigator: Yomna Bayoumi, MD Cairo University
Tracking Information
First Submitted Date  ICMJE May 20, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date July 27, 2020
Actual Study Start Date  ICMJE July 15, 2019
Actual Primary Completion Date May 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2020)
  • Percentage of women entering active phase within 24 hours of administering castor oil/placebo [ Time Frame: two weeks ]
    Actual time of delivery
  • number of successful VBAC cases [ Time Frame: 24 hours ]
    number of successful cases who delivered vaginally
Original Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019) 		Delivery within 24 hours of administering castor oil/placebo [ Time Frame: two weeks ]
Actual time of delivery
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2020)
  • 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
  • duration of labor [ Time Frame: 24 hours ]
    duration of labor in hours
  • number of cases needing oxytocin augmentation [ Time Frame: 24 hours ]
    number of cases needing oxytocin augmentation
Original Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Castror Oil for Labor Induction in Women With Previous Cesarean Section
Official Title  ICMJE The Use of Castor Oil for Induction of Labour in Women With Previous Caesarean Delivery: a Randomized Controlled Trial
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.
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 80 healthy pregnant women with a hsitory 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 delivaries after cesarean.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Induction of Labor
Intervention  ICMJE
  • Drug: Castor Oil
    The intervention group will be given 60 mL of castor oil in 140 mL of orange juice
  • Drug: placebo
    the control group will be given a sunflower oil as a placebo with a similar texture to castor oil
Study Arms  ICMJE
  • Experimental: castor oil group
    60 mL of castor oil in 140 mL of orange juice
    Intervention: Drug: Castor Oil
  • Placebo Comparator: placebo group
    Patients will receive sunflower oil as a placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2020) 		80
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2019) 		100
Actual Study Completion Date  ICMJE July 15, 2020
Actual Primary Completion Date May 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 18 years old, gestational age ≥ 39 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03958981
Other Study ID Numbers  ICMJE castor oil
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ahmed Samy aly ashour, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE
  • Mohamed El Sharkawy
  • Yomna Bayoumi
  • mohamed hisham gouda
  • Dina latif
Investigators  ICMJE
Principal Investigator: Yomna Bayoumi, MD Cairo University
PRS Account Cairo University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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