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

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regenex Pharmaceutical, China
• Treatments: Misoprostol

Criteria

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.