The Effect of Dates and Castor Oil on the Initiation of Spontaneous Labor in Primigravida Parturients

The Effect of Dates and Castor Oil on the Initiation of Spontaneous Labor in Primigravida Parturients- a Prospective Randomized Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Effect of Dates and Castor Oil on Spontaneous Labor
• Intervention / Treatment: Dietary supplement: Dates; Dietary supplement: Castor oil

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nir Kugelman, MD; Phone Number: 972-546830804; Email: nirkug@gmail.com

Study Locations

• Israel
  • Haifa, Israel
    • Carmel Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Experimental: Date consumption; Consumption of 6 dates a day until 41 weeks of gestation	Dietary supplement: Dates; Consumption of 6 dates a days until 41 weeks of gestation
Experimental: Castor oil consumption; One time consumption of 60 CC of Castor oil	Dietary supplement: Castor oil; One time consumption of 60 CC Castor oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of spontaneous entry into labor	Rate of women who will enter labor spontaneously without intervention	2 weeks after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical ripening- Bishop score	Change of cervical ripening status after intervention	2 weeks after enrollment

Collaborators and Investigators

• Sponsor: Carmel Medical Center
• Investigators: Study Director: Lena Sagi-Dain, MD, Lady Davis Carmel Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): August 24, 2021
• Primary Completion (Anticipated): January 30, 2022
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: August 17, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 18, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cathartics; Castor Oil
• Other Study ID Numbers: CMC-21-0064-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No