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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01428037
Other study ID # RH-MS-01RCT
Secondary ID
Status Completed
Phase Phase 3
First received August 31, 2011
Last updated November 21, 2013
Start date March 2012
Est. completion date January 2013

Study information

Verified date November 2013
Source Regenex Pharmaceutical, China
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 225
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
One tablet vaginal inserted at 4 hrly interval with maximum of three doses
Misoprostol vaginal Tablet 25 mcg
One tablet vaginal insert at 4 hrly interval with maximum of three doses

Locations

Country Name City State
China Sichuan Provincial People's Hospital Chengdu Sichuan
China Southwest Hospital Chongqing
China The First Affliated Hospital with Nanjing Meical Uniersity Nanjing Jiangsu
China Zhongda Hospital ,Southeast University Nanjing Jiangsu
China Renji Hospital, Shanghai Jiaotong University School of Medicine Shanghai
China The International Peace Maternity & Child Care of China Welfare Institute Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Regenex Pharmaceutical, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment success rate Treatment success is defined as: ?3 of Bishop score increased within 12 hours or Vaginal delivery within 24 hours. From the first dose to 12-24 hours No
Secondary Percentage of participants of labor onset within 24 hours From the first dose to 24 hours No
Secondary Time from 1st dose to labor onset From the first dose to labor onset No
Secondary Need for augmentation of labor with oxytocin From the first dose to neonate delivery No
Secondary Rate and reason for Cesarean Section From the first dose to neonate delivery No
See also
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Completed NCT01139801 - Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon N/A
Active, not recruiting NCT06324279 - Cervical Sliding Sign to Predict Outcome of Induction of Labor
Recruiting NCT05864326 - Heated Saline in Cervical Balloon for Labor Induction, a RCT N/A
Active, not recruiting NCT06056141 - Induction of Labour at Term With Low Dose Oral Misoprostol Versus a Foley Catheter Phase 4
Completed NCT04529837 - Ultrasound Assessment of DILAPAN-S
Completed NCT02477085 - Methods of Labor Induction and Perinatal Outcomes
Completed NCT03138252 - Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin Phase 3
Completed NCT02098421 - Foley Labor Induction Trial at Term and in PROM Phase 1
Recruiting NCT01720394 - Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert Phase 4
Completed NCT00451308 - Induction of Labor With a Foley Balloon Catheter: Inflation With 30ml Compared to 60ml Phase 4
Not yet recruiting NCT05511727 - Use of Single Versus Double Foley's Catheter in Pre-induction Cervical Ripening N/A
Recruiting NCT02762942 - Comparison of Vaginal Misoprostol Plus Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor Phase 4
Completed NCT01283022 - Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study) Phase 2
Recruiting NCT00684606 - Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor N/A
Recruiting NCT05759364 - The Effect of IV PAPAVERINE 80 mg Prior to Catheter Balloon Insertion on Bishop Score and Pain N/A
Recruiting NCT03854383 - Using Isosorbide Mononitrate in Reducing Time in Induction of Labor in Post Date Women Phase 2
Terminated NCT03752073 - Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix N/A
Recruiting NCT03045939 - Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours N/A
Completed NCT03976037 - Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb Early Phase 1