Cervical RipeningPhase 3NCT01428037
Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor
A Phase 3 study testing Misoprostol vaginal Tablet 25 mcg in people with Cervical Ripening and Induction of Labor, run by Regenex Pharmaceutical, China at 6 sites in China.
Trial summary
The purpose of this study is to estimate the efficacy and safety of the 25mcg vaginal misoprostol for cervical ripening and induction of labour. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Cervical Ripening, Induction of Labor
- What is being tested?
- Misoprostol vaginal Tablet 25 mcg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 6 sitesChina
- Study dates
- Mar 2012to Jan 2013
- Phase
- Phase 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Singleton pregnancy.
- Aged 20 years or older.
- At term (37 to 42 weeks inclusive gestation).
- Cephalic presentation (normal lie).
- No rupture.
- Bishop score ≤6.
- With an indication for labour induction.
- Written informed consent.
Who cannot join
- Any contraindication to vaginal delivery.
- Previous of uterine scar(Cesarean section or other uterine surgeries).
- Heavy or repeated vaginal bleeding in third trimester of pregnancy.
- Have a history of glaucoma,asthma or epilepsy.
- Contraindication to prostaglandin use.
- Known severe allergy to prostaglandin.
Show all 25Show fewer
- Placenta previa
- Premature rupture of membranes
- Placental abruption
- Fetal malpresentation(Breech or Transverse)
- Obvious cephalopelvic disproportion
- Amniotic Fluid Index more than 250mm or less than 50mm
- Fetal growth restriction
- Fetal malformation
- Fetal distress
- Preeclampsia or eclampsia
- Fetal macrosomia of prenatal diagnosis(B-type ultrasonic inspection/Abdomen estimates)
- Intrahepatic cholestasis syndrome(ICP)
- Pregnancy with severe heart, lung, liver, kidney, endocrine disease and immune dysfunction
- Pregnancy with acute systemic infection
- Pregnancy with Severe anemia
- Cervical carcinoma
- Some genital tract infection disease, such as active herpes infection
- Take part in other clinical trials within three months.
- The person that investigator thought not be enrolled.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Southwest Hospital
Chongqing, 400038
Zhongda Hospital ,Southeast University
Nanjing, Jiangsu, 210009
The First Affliated Hospital with Nanjing Meical Uniersity
Nanjing, Jiangsu, 210029
The International Peace Maternity & Child Care of China Welfare Institute
Shanghai, 200030
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200127
About this study
Official title: A Randomized,Double-blind,Placebo-controlled, Multicenter Study of the Efficacy and Safety of Vaginal Misoprostol for Cervical Ripening and Induction of Labor
The purpose of this study is to estimate the efficacy and safety of the 25mcg vaginal misoprostol for cervical ripening and induction of labour.
Read the detailed description
There are many pregnant women require medical intervention to induce labor for some reasons at term. There are two fundamental changes that characterize pre-labor preparation for delivery: sensitization of the myometrium to produce contractions, and ripening (softening and dilation) of the cervix. A synthetic Prostaglandin misoprostol is fundamental to both of these changes. Low dose misoprostol is effective and safe for labor induction and has been used widely.
Oral tablets(200mcg) are broken into fragments and used intravaginally to ripen the cervix and induce labor due to the disadvantages of existing cervical ripeners (delivery of bolus doses, freezer or refrigerated storage, lack of efficacy in labor induction), and due to safety concerns with the off-label use of oral misoprostol tablet fragments, Regenex Corporation has developed a vaginal tablet with 25mcg misoprostol.
The primary objective of the study was to assess of the efficacy and safety of low dose (25 mcg) of misoprostol vaginal tablet for cervical ripening and induction of labour.
- Conditions
- Cervical Ripening, Induction of Labor
- Being tested
- Placebo, Misoprostol vaginal Tablet 25 mcg
- Keywords
- Vaginal Misoprostol, Cervical Ripening, Labor Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
One tablet vaginal inserted at 4 hrly interval with maximum of three doses
Misoprostol vaginal Tablet 25 mcgDrug
Also called Misoprostol vaginal Tablet
One tablet vaginal insert at 4 hrly interval with maximum of three doses
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol Vagianl Tablet | Experimental | Misoprostol Vaginal Tablet 25 mcg. Receives: Drug: Misoprostol vaginal Tablet 25 mcg |
| Placebo | Placebo comparator | Tablet without active ingredient Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success rate
Treatment success is defined as: ≧3 of Bishop score increased within 12 hours or Vaginal delivery within 24 hours.
Measured: From the first dose to 12-24 hours
Secondary outcomes (4)
Percentage of participants of labor onset within 24 hours
Measured: From the first dose to 24 hours
Time from 1st dose to labor onset
Measured: From the first dose to labor onset
Need for augmentation of labor with oxytocin
Measured: From the first dose to neonate delivery
Rate and reason for Cesarean Section
Measured: From the first dose to neonate delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2011 (estimated)
- Study startMar 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RipeningStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regenex Pharmaceutical, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen Di, MD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428037
- Sponsor's protocol ID
- RH-MS-01RCT
- Status last verified
- Nov 2013
- First submitted
- 31 Aug 2011
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized,Double-blind,Placebo-controlled, Multicenter Study of the Efficacy and Safety of Vaginal Misoprostol for Cervical Ripening and Induction of Labor
- ClinicalTrials.gov ID
- NCT01428037
- Acronym / sponsor ID
- RH-MS-01RCT
- Conditions
- Cervical Ripening, Induction of Labor
- Keywords
- Vaginal Misoprostol, Cervical Ripening, Labor Induced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Regenex Pharmaceutical, ChinaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 2 Sep 2011 (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 this study is to estimate the efficacy and safety of the 25mcg vaginal misoprostol for cervical ripening and induction of labour.
Detailed description
There are many pregnant women require medical intervention to induce labor for some reasons at term. There are two fundamental changes that characterize pre-labor preparation for delivery: sensitization of the myometrium to produce contractions, and ripening (softening and dilation) of the cervix. A synthetic Prostaglandin misoprostol is fundamental to both of these changes. Low dose misoprostol is effective and safe for labor induction and has been used widely.
Oral tablets(200mcg) are broken into fragments and used intravaginally to ripen the cervix and induce labor due to the disadvantages of existing cervical ripeners (delivery of bolus doses, freezer or refrigerated storage, lack of efficacy in labor induction), and due to safety concerns with the off-label use of oral misoprostol tablet fragments, Regenex Corporation has developed a vaginal tablet with 25mcg misoprostol.
The primary objective of the study was to assess of the efficacy and safety of low dose (25 mcg) of misoprostol vaginal tablet for cervical ripening and induction of labour.
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 |
|---|---|---|
| Misoprostol Vagianl Tablet | Experimental | Drug: Misoprostol vaginal Tablet 25 mcgMisoprostol Vaginal Tablet 25 mcg. |
| Placebo | Placebo comparator | Drug: PlaceboTablet without active ingredient |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Singleton pregnancy.
- Aged 20 years or older.
- At term (37 to 42 weeks inclusive gestation).
- Cephalic presentation (normal lie).
- No rupture.
Key exclusion criteria (25 listed)
- Any contraindication to vaginal delivery.
- Previous of uterine scar(Cesarean section or other uterine surgeries).
- Heavy or repeated vaginal bleeding in third trimester of pregnancy.
- Have a history of glaucoma,asthma or epilepsy.
- Contraindication to prostaglandin use.
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 |
|---|---|---|
| PlaceboOne tablet vaginal inserted at 4 hrly interval with maximum of three doses | Drug | Placebo |
| Misoprostol vaginal Tablet 25 mcgAlso: Misoprostol vaginal TabletOne tablet vaginal insert at 4 hrly interval with maximum of three doses | Drug | Misoprostol Vagianl Tablet |
Primary outcome
Treatment success rate
Time frame: From the first dose to 12-24 hours
Treatment success is defined as: ≧3 of Bishop score increased within 12 hours or Vaginal delivery within 24 hours.
4 secondary outcomes
Percentage of participants of labor onset within 24 hours
Time frame: From the first dose to 24 hours
Time from 1st dose to labor onset
Time frame: From the first dose to labor onset
Need for augmentation of labor with oxytocin
Time frame: From the first dose to neonate delivery
Rate and reason for Cesarean Section
Time frame: From the first dose to neonate delivery
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 25 Nov 2013.
Related trials for Cervical Ripening
RecruitingPhase 2/3
Impact of Standardization on Outcomes Following Cervical Ripening
Pregnancy
Recruiting
Cervical Ripening Balloons for Same-Day Cervical Prep
Dilation and Evacuation
Not yet recruiting
Improving the Childbirth Experience for Women Who Have Undergone Cervical Ripening by Involving Them in the Choice of Ripening Technique
Pregnancy, Cervical Ripening
Not yet recruiting
Safety and Feasibility of the INGA Sensor System for Fetal and Uterine Monitoring During Cervical Ripening
Induced Labor, Cervical Ripening
Not yet recruiting
Outcome of Concurrent Versus Sequential Method of Induction of Labour in Term Pregnancy
Induced; Birth
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.
Wen Di, MD principal investigator
RenJi Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Misoprostol vaginal Tablet 25 mcg in people with Cervical Ripening and Induction of Labor, run by Regenex Pharmaceutical, China at 6 sites in China.
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 8 inclusion and 25 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 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. 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 phase mean?
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?
Treatment success rate (time frame: From the first dose to 12-24 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 25 Nov 2013.