Failed Induction of LaborPhase 2/3NCT02485821
Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol
A Phase 2/3 study testing Estradiol and Misoprostol in people with Failed Induction of Labor, run by Ain Shams University at 1 site in Egypt.
Trial summary
To assess the effect of vaginal estradiol pretreatment before vaginal misoprostol on labor induction. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Failed Induction of Labor
- What is being tested?
- Estradiol and Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2015to Feb 2016
- Phase
- Phase 2/3
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Maternal age ≥ 18 years old.
- Gestational age ≥ 37 wks to 41 wks.
- BMI between 20 kg/m2 and 35kg/m2.
- Vertex presentation.
- Singleton pregnancy.
Who cannot join
- Multiple pregnancy.
- Non vertex presentation.
- Absolute or relative contraindication to vaginal delivery e.g. (Placenta previa, fibroid uterus, uterine anomalies, previous uterine surgery).
- PROM.
- IUFD.
- Fetal distress.
Trial locations and contacts
1 site in 1 country.
About this study
To assess the effect of vaginal estradiol pretreatment before vaginal misoprostol on labor induction.
Read the detailed description
A prospective double blind randomized clinical trial. Conducted at Ain Shams University Maternity Hospital. Patients fulfilling inclusion and exclusion criteria will be divided into two groups. Group (A):
100 patient will receive single dose vaginal estradiol 50mcg tablet (Ethinyl Estradiol manufactured by KAHIRA Pharmaceutical company) and vaginal misoprostol 25mcg tablet (Vagiprost manufactured by ADWIA Pharmaceutical company), misoprostol alone will repeated every 6hours up to five doses.
Group (B):
100 patients will receive placebo vaginally and misoprostol 25 mcg which will be repeated every 6 hours up to five doses.
Primary Outcome
- Measure the time to cervical ripening. Secondary Outcome
- Measure the time to active labor.
- Number of misoprostol doses.
- Induction delivery time.
- Time to achieve vaginal delivery.
- Fetal outcome (Apgar score).
- Conditions
- Failed Induction of Labor
- Being tested
- Estradiol, Placebo, Misoprostol
- Keywords
- Estradiol, Misoprostol, Induction of labor, Cervical ripening, Bishop score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstradiolDrug
Also called Ethinyl Estradiol
PlaceboDrug
MisoprostolDrug
Also called Vagiprost
| Study group | Role | What they receive |
|---|---|---|
| Estradiol + Misoprostol | Experimental | 100 patient will receive single dose vaginal estradiol 50mcg tablet (Ethinyl Estradiol manufactured by KAHIRA Pharmaceutical company) and vaginal misoprostol 25mcg tablet (Vagiprost manufactured by ADWIA Pharmaceutical company), misoprostol alone will repeated every 6hours up to five doses. Receives: Drug: Estradiol; Drug: Misoprostol |
| Placebo + Misoprostol | Placebo comparator | 100 patients will receive placebo vaginally and misoprostol 25 mcg which will be repeated every 6 hours up to five doses. Receives: Drug: Placebo; Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to cervical ripening.
Measured: 24 hours
Secondary outcomes (3)
Time to active labor
Measured: 30 hours
Number of misoprostol doses
Measured: 24 hours
Induction delivery time
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failed Induction of LaborStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed S Sweed, MD, Ain Shams University
- Investigators
- Osama El-Kady, MD, Principal investigator, AinShams UniversityAbdEl-Latif El-Kholy, MD, Principal investigator, AinShams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485821
- Sponsor's protocol ID
- MS39825273
- Status last verified
- Feb 2016
- First submitted
- 19 Jun 2015
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol
- ClinicalTrials.gov ID
- NCT02485821
- Acronym / sponsor ID
- MS39825273
- Conditions
- Failed Induction of Labor
- Keywords
- Estradiol, Misoprostol, Induction of labor, Cervical ripening, Bishop score
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 30 Jun 2015 (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.
To assess the effect of vaginal estradiol pretreatment before vaginal misoprostol on labor induction.
Detailed description
A prospective double blind randomized clinical trial. Conducted at Ain Shams University Maternity Hospital. Patients fulfilling inclusion and exclusion criteria will be divided into two groups. Group (A):
100 patient will receive single dose vaginal estradiol 50mcg tablet (Ethinyl Estradiol manufactured by KAHIRA Pharmaceutical company) and vaginal misoprostol 25mcg tablet (Vagiprost manufactured by ADWIA Pharmaceutical company), misoprostol alone will repeated every 6hours up to five doses.
Group (B):
100 patients will receive placebo vaginally and misoprostol 25 mcg which will be repeated every 6 hours up to five doses.
Primary Outcome
- Measure the time to cervical ripening. Secondary Outcome
- Measure the time to active labor.
- Number of misoprostol doses.
- Induction delivery time.
- Time to achieve vaginal delivery.
- Fetal outcome (Apgar score).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Estradiol + Misoprostol | Experimental | Drug: Estradiol, Drug: Misoprostol100 patient will receive single dose vaginal estradiol 50mcg tablet (Ethinyl Estradiol manufactured by KAHIRA Pharmaceutical company) and vaginal misoprostol 25mcg tablet (Vagiprost manufactured by ADWIA Pharmaceutical company), misoprostol alone will repeated every 6hours up to five doses. |
| Placebo + Misoprostol | Placebo comparator | Drug: Placebo, Drug: Misoprostol100 patients will receive placebo vaginally and misoprostol 25 mcg which will be repeated every 6 hours up to five doses. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Maternal age ≥ 18 years old.
- Gestational age ≥ 37 wks to 41 wks.
- BMI between 20 kg/m2 and 35kg/m2.
- Vertex presentation.
- Singleton pregnancy.
Key exclusion criteria (6 listed)
- Multiple pregnancy.
- Non vertex presentation.
- Absolute or relative contraindication to vaginal delivery e.g. (Placenta previa, fibroid uterus, uterine anomalies, previous uterine surgery).
- PROM.
- IUFD.
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 |
|---|---|---|
| EstradiolAlso: Ethinyl Estradiol | Drug | Estradiol + Misoprostol |
| Placebo | Drug | Placebo + Misoprostol |
| MisoprostolAlso: Vagiprost | Drug | Estradiol + Misoprostol, Placebo + Misoprostol |
Primary outcome
Time to cervical ripening.
Time frame: 24 hours
3 secondary outcomes
Time to active labor
Time frame: 30 hours
Number of misoprostol doses
Time frame: 24 hours
Induction delivery time
Time frame: 48 hours
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 17 Feb 2016.
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.
Osama El-Kady, MD principal investigator
AinShams University
AbdEl-Latif El-Kholy, MD principal investigator
AinShams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Estradiol and Misoprostol in people with Failed Induction of Labor, run by Ain Shams University at 1 site in Egypt.
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 5 inclusion and 6 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 17 Feb 2016. 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 Egypt. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to cervical ripening. (time frame: 24 hours). 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 17 Feb 2016.