Prolonged PregnancyNCT00244738
The Use of Castor Oil as a Labor Initiator in Post-date Pregnancies
A study testing Castor oil and Sunflower oil in people with Prolonged Pregnancy, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The purpose of the study is to determine whether castor oil is effective in inducing labor. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prolonged Pregnancy
- What is being tested?
- Castor oil and Sunflower oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2006to Sep 2010
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women at 40-42 weeks gestation
- Good obstetrical dating
- Singleton
- Intact membranes
- Preinterventional Bishop score less than or equals 4
- No evidence of effective uterine contractions by external tocography
- Living close to hospital
Who cannot join
- Multiple gestation
- Oligohydramnios or Polyhydramnios
- Abnormal FHR tracing
- Obstetric complication (hypertension, bleeding)
- Ruptured membranes
- Suspected intrauterine growth restriction
Show all 10Show fewer
- Biophysical score < 8
- Previous cesarean section / myomectomy / Other uterine operation
- Fever, malaise at recruitment
- Chronic illness (renal, hepatic, endocrine)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to determine whether castor oil is effective in inducing labor.
Read the detailed description
Castor oil is traditionally given by midwives in order to induce labor. Its efficacy as an initiator of labor was previously tested only in one clinical trial. Unfortunately this study (by Garry et al.) was not sufficiently controlled.
We intent to recruit 84 healthy pregnant women with no contraindication to vaginal delivery that had past their due date. Women will be randomly and blindly divided into equal sized intervention group and control group. Intervention group will be given 60 mL of castor oil in 140 mL of orange juice, while control group will be given a placebo with similar texture. Primary outcome to be tested is the percentage of women entering active labor within 24 hours of administration.
- Conditions
- Prolonged Pregnancy
- Being tested
- Castor oil, Sunflower oil
- Keywords
- pregnancy, post-date, induction of labor, castor oil
- Medical subject headings
- Pregnancy, Prolonged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Castor oilDietary supplement
Patients who received castor oil for labor induction
Sunflower oilDietary supplement
Patients who received sunflower oil as a placebo
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Patients who received castor oil for labor induction Receives: Dietary Supplement: Castor oil |
| Control | Placebo comparator | Patients who received sunflower oil as a placebo Receives: Dietary Supplement: Sunflower oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery within 24 hours of administering castor oil/placebo
Actual time of delivery
Measured: two weeks
Secondary outcomes (4)
Neonatal apgar scores
Neonatal APGAR scores
Measured: 1 minute and 5 minute after delivery
Umbilical artery pH and Base Excess
Umbilical artery gases
Measured: Immediately at birth
Neonatal complications including hospitalization in NICU
Were there any admissions to NICU, what was the reason ?
Measured: immediately after birth
Mode of delivery (ie. Normal delivery Vs. Cesarean delivery)
Mode of delivery
Measured: Within two weeks of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2005 (estimated)
- Study startFeb 2006
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prolonged PregnancyStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shay Porat, MD, Principal investigator, Hadassah Medical OrganizationDrorit Hochner-Celnikier, MD, Study director, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244738
- Sponsor's protocol ID
- CASTOR- HMO-CTIL
- Status last verified
- Nov 2005
- First submitted
- 26 Oct 2005
- Last updated
- 20 Mar 2012
- Results posted
- No
Publications
Garry D, Figueroa R, Guillaume J, Cucco V. Use of castor oil in pregnancies at term. Altern Ther Health Med. 2000 Jan;6(1):77-9.
PubMed 10631825
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Castor Oil as a Labor Initiator in Post-date Pregnancies
- ClinicalTrials.gov ID
- NCT00244738
- Acronym / sponsor ID
- CASTOR- HMO-CTIL
- Conditions
- Prolonged Pregnancy
- Keywords
- pregnancy, post-date, induction of labor, castor oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 27 Oct 2005 (estimated)
- 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.
The purpose of the study is to determine whether castor oil is effective in inducing labor.
Detailed description
Castor oil is traditionally given by midwives in order to induce labor. Its efficacy as an initiator of labor was previously tested only in one clinical trial. Unfortunately this study (by Garry et al.) was not sufficiently controlled.
We intent to recruit 84 healthy pregnant women with no contraindication to vaginal delivery that had past their due date. Women will be randomly and blindly divided into equal sized intervention group and control group. Intervention group will be given 60 mL of castor oil in 140 mL of orange juice, while control group will be given a placebo with similar texture. Primary outcome to be tested is the percentage of women entering active labor within 24 hours of administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: Castor oilPatients who received castor oil for labor induction |
| Control | Placebo comparator | Dietary Supplement: Sunflower oilPatients who received sunflower oil as a placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Pregnant women at 40-42 weeks gestation
- Good obstetrical dating
- Singleton
- Intact membranes
- Preinterventional Bishop score less than or equals 4
Key exclusion criteria (10 listed)
- Multiple gestation
- Oligohydramnios or Polyhydramnios
- Abnormal FHR tracing
- Obstetric complication (hypertension, bleeding)
- Ruptured membranes
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 |
|---|---|---|
| Castor oilPatients who received castor oil for labor induction | Dietary supplement | Intervention |
| Sunflower oilPatients who received sunflower oil as a placebo | Dietary supplement | Control |
Primary outcome
Delivery within 24 hours of administering castor oil/placebo
Time frame: two weeks
Actual time of delivery
4 secondary outcomes
Neonatal apgar scores
Time frame: 1 minute and 5 minute after delivery
Umbilical artery pH and Base Excess
Time frame: Immediately at birth
Neonatal complications including hospitalization in NICU
Time frame: immediately after birth
Mode of delivery (ie. Normal delivery Vs. Cesarean delivery)
Time frame: Within two weeks of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
- Background: PubMed 10631825Garry D, Figueroa R, Guillaume J, Cucco V. Use of castor oil in pregnancies at term. Altern Ther Health Med. 2000 Jan;6(1):77-9.
Related trials for Prolonged Pregnancy
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Not yet recruitingPhase 2
CAffeine Use in Prolonged Oxygen Use in meConium aspIration Syndrome in Neonatal Outcomes (CAPUCINO)
Meconium Aspiration Syndrome
RecruitingPhase 2
Is Prolonged Systemic Immunotherapy Necessary After Achieving Tumor-free Status in Patients With Extensive Transurethrally Unresectable Very-high-risk NMIBC?
Bladder (Urothelial, Transitional Cell) Cancer, Non Muscle Invasive Bladder Cancer
Recruiting
Maternal Maneuvers During Prolonged Labor
Labor Stage, First, Prolonged Labor
RecruitingObservational study
uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto
Urothelial Carcinoma, Urothelial Carcinoma Recurrent
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.
Shay Porat, MD principal investigator
Hadassah Medical Organization
Drorit Hochner-Celnikier, MD study director
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Castor oil and Sunflower oil in people with Prolonged Pregnancy, run by Hadassah Medical Organization 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 10 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: finished, as of the sponsor's last update on 20 Mar 2012. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delivery within 24 hours of administering castor oil/placebo (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00244738, which also lists 1 linked publication.
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 20 Mar 2012.