Effect of Dates and Castor Oil on Spontaneous LaborNCT05013151
The Effect of Dates and Castor Oil on the Initiation of Spontaneous Labor in Primigravida Parturients
A study testing Dates and Castor oil in people with Effect of Dates and Castor Oil on Spontaneous Labor, run by Carmel Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Effect of Dates and Castor Oil on Spontaneous Labor
- What is being tested?
- Dates and Castor oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteIsrael
- Study dates
- 24 Aug 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Dates, Castor oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DatesDietary supplement
Consumption of 6 dates a days until 41 weeks of gestation
Castor oilDietary supplement
One time consumption of 60 CC Castor oil
| Study group | Role | What they receive |
|---|---|---|
| Date consumption | Experimental | Consumption of 6 dates a day until 41 weeks of gestation Receives: Dietary Supplement: Dates |
| Castor oil consumption | Experimental | One time consumption of 60 CC of Castor oil Receives: Dietary Supplement: Castor oil |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of spontaneous entry into labor
Rate of women who will enter labor spontaneously without intervention
Measured: 2 weeks after enrollment
Secondary outcomes (1)
Cervical ripening- Bishop score
Change of cervical ripening status after intervention
Measured: 2 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start24 Aug 2021 (estimated)
- Primary completion30 Jan 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Dates and Castor Oil on Spontaneous LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nir Kugelman, Carmel Medical Center
- Investigators
- Lena Sagi-Dain, MD, Study director, Lady Davis Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013151
- Sponsor's protocol ID
- CMC-21-0064-CTIL
- Status last verified
- Aug 2021
- First submitted
- 17 Aug 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dates and Castor Oil on the Initiation of Spontaneous Labor in Primigravida Parturients- a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT05013151
- Acronym / sponsor ID
- CMC-21-0064-CTIL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- 24 Aug 2021 (estimated)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Date consumption | Experimental | Dietary Supplement: DatesConsumption of 6 dates a day until 41 weeks of gestation |
| Castor oil consumption | Experimental | Dietary Supplement: Castor oilOne time consumption of 60 CC of Castor oil |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DatesConsumption of 6 dates a days until 41 weeks of gestation | Dietary supplement | Date consumption |
| Castor oilOne time consumption of 60 CC Castor oil | Dietary supplement | Castor oil consumption |
Primary outcome
Rates of spontaneous entry into labor
Time frame: 2 weeks after enrollment
Rate of women who will enter labor spontaneously without intervention
1 secondary outcome
Cervical ripening- Bishop score
Time frame: 2 weeks after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lena Sagi-Dain, MD study director
Lady Davis Carmel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dates and Castor oil in people with Effect of Dates and Castor Oil on Spontaneous Labor, run by Carmel Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nir Kugelman, MD (972-546830804, nirkug@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of spontaneous entry into labor (time frame: 2 weeks after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.