None listed
Conditions
Interventions
Experimental Group:Treatment with test drug
Sponsors
PEKING UNIVERSITY FIRST HOSPITAL
Eligibility
Sex/Gender
Female
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=20 years; 2. Single pregnant women with first live fetus, unbroken membrane, cervical Bishop score =41 weeks, gestational hypertension (gestational hypertension, mild preeclampsia), gestational diabetes, severe fetal growth restriction, fetal factors (oligohydramniotic fluid, placental insufficiency), etc. 3. Subjects without contraindications to vaginal delivery; 4. Subjects must voluntarily participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Allergic to misoprostol or any excipient; 2. Labor has already begun; 3. Those who have used other methods to induce labor before drug administration; 4. Before the use of this product, it is suspected or there is evidence that the life of the fetus is in danger [such as negative type of non-stress test (NST), no response type or positive stress test (CST), amniotic fluid meconium contamination or suspected fetal distress and can not tolerate contractions]; 5. Those who are using oxytocin and/or other drugs to induce labor; 6. Suspect or have evidence of scar in the uterus or cervix, or uterine fibroids or adenomyosis; 7. Abnormal uterine development (e.g., bichorned uterus), which is not expected to deliver vaginally; 8. Placenta previa or unexplained prenatal vaginal bleeding; 9. Patients with acute pelvic inflammatory disease; 10. Patients with abnormal fetal exposure who are expected to be unable to deliver vaginally; 11. Pregnant women with preeclampsia [such as those with hemolytic anemia, elevated liver enzymes, low platelet count (HELLP) syndrome, other end-organ diseases or neurological symptoms other than mild headache] with suspected or evidence of intrauterine distress and inability to tolerate contractions; 12. Patients with asthma, glaucoma, severe heart and liver (ALT/AST>= upper limit of normal), kidney (BUN or urea > upper limit of normal) and other system damage, or malignant tumors (such as cervical cancer), or any other diseases or physiological conditions that may affect the test results; 13. A history of sudden labor or more than 3 times of full-term labor; 14. Patients are participating in other clinical trials and have used drugs or medical devices that may affect the efficacy and/or safety evaluation of the study; 15. The investigator considers any other reason for ineligibility to participate in the clinical trial that might affect the efficacy and/or safety evaluation of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects with cervical Bishop score improvement greater than 3 points;Labor rate;Vaginal delivery rate;Labor start time;The proportion of subjects requiring additional oxytocin;Percentage of subjects undergoing cesarean section;Birth process time;Neonatal situation; | — |
Countries
China
Contacts
Public ContactYang Huixia
PEKING UNIVERSITY FIRST HOSPITAL
Outcome results
None listed