High risk pregnancy
Conditions
Interventions
Misoprostol vaginal tablets exposure group:NA
Misoprostol vaginal tablets non-exposed group:NA
Sponsors
Guangzhou Women and Children Medical Center
Eligibility
Sex/Gender
Female
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Pregnant women with a full-term cervical Bishop score of =6, with a single head first, with indication for induction of labor and no contraindications for the mother or child; 2. Subjects who are assessed by the investigator to be able to use the product; 3. The subject or (his/her legal guardian) understands the study and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. those who are allergic to misoprostol or any excipients; 2. those in whom labor has already begun; 3. who have suspected or have evidence of a life-threatening fetal condition prior to the administration of this product (e.g., negative non-stress test (NST) non-responsive or positive stress test (CST), contamination of amniotic fluid with meconium, or suspected intrauterine distress of the fetus with intolerance of contractions); 4. those who are inducing labor with the use of oxytocin and/or other medications; 5. those with suspicion or evidence of scarring of the uterus or uteri 6. those with abnormal uterine development (e.g., bicornuate uterus) who are not expected to deliver vaginally 7. patients with placenta praevia and unexplained antepartum vaginal bleeding; 8. Abnormal prenatal presentation of the fetus, where vaginal delivery is not expected; 9. pregnant women with preeclampsia should be excluded if there is suspicion or evidence of intrauterine distress and intolerable contractions; patients with severe preeclampsia with hemolytic anemia, elevated liver enzymes, low platelet count (HELLP) syndrome, other end-organ disease, or neurological symptoms other than mild headache; 10 Those with severe hepatic insufficiency and renal failure (GFR <15 ml/min/1.73 m2); 11 Subjects deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of =3-point improvement in Bishop score from baseline after treatment with misoprostol vaginal tablets; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of Bishop score >6 after treatment with misoprostol vaginal tablets;Delivery rate within 24 hours of first dose of medication;Rate of vaginal delivery within 24 hours;Duration of labor;Incidence of premature rupture of membranes;Amniotic fluid fecal contamination;Cesarean section rate;Oxytocin utilization rate;Postpartum hemorrhage;Incidence of puerperal infections;Neonatal Apgar score; | — |
Countries
China
Contacts
Public ContactFang Dajun
Guangzhou Women and Children Medical Center
Outcome results
None listed