The Effect of Dates and Castor Oil on the Initiation of Spontaneous Labor in Primigravida Parturients
1 other identifier
interventional
450
1 country
1
Brief Summary
Finding a natural and efficient method to improve the chance of entering spontaneous labor beyond 39 weeks of gestation will address both the medical necessity and the will of many parturients to avoid medical interventions. In this study we aim to evaluate the effect of dates and castor oil on the initiation of spontaneous labor in primigravida parturients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2021
CompletedFirst Posted
Study publicly available on registry
August 19, 2021
CompletedStudy Start
First participant enrolled
August 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedAugust 19, 2021
August 1, 2021
5 months
August 17, 2021
August 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Rates of spontaneous entry into labor
Rate of women who will enter labor spontaneously without intervention
2 weeks after enrollment
Secondary Outcomes (1)
Cervical ripening- Bishop score
2 weeks after enrollment
Study Arms (3)
Date consumption
EXPERIMENTALConsumption of 6 dates a day until 41 weeks of gestation
Castor oil consumption
EXPERIMENTALOne time consumption of 60 CC of Castor oil
Control Group
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- Pregnant women who come to the obstetrical emergency department for normal check up between 39+4 and 40+2 weeks of gestation
- Primipara
- Bishop cervical score below 5
- Low risk pregnancy
- Singleton pregnancy
- Vertex presentation
- Women who haven't consumed dates over once a week in month prior the checkup and haven't consumed castor oil prior to enrollment.
You may not qualify if:
- Any medical indication for labor induction
- Regular contractions
- Premature rupture of membranes
- Women who consumed dates over once a week in month prior the checkup or consumed castor oil prior to enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Carmel Medical Center
Haifa, Israel
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lena Sagi-Dain, MD
Lady Davis Carmel Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Nir Kugelman
Study Record Dates
First Submitted
August 17, 2021
First Posted
August 19, 2021
Study Start
August 24, 2021
Primary Completion
January 30, 2022
Study Completion
February 28, 2022
Last Updated
August 19, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share