Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor

Regenex Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Cervical Ripening

Induction of Labor

Treatments

Drug: Misoprostol vaginal Tablet 25 mcg

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01428037

RH-MS-01RCT

Details and patient eligibility

About

The purpose of this study is to estimate the efficacy and safety of the 25mcg vaginal misoprostol for cervical ripening and induction of labour.

Full 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.

Enrollment

225 patients

Sex

Female

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.