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IRCT20230611058454N1 IRCT 2023-06-24 Tehran University of Medical Sciences The effect of misoprostol alone and misoprostol together with vaginal estrogen in induction of labor Comparison of the effect of misoprostol alone and misoprostol together with vaginal estrogen in preparing the cervix and induction of labor in term pregnancies 2023-07-23 anticipated 200 Complete https://irct.ir/trial/70714 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation rule: First, 100 letters A and 100 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A (misoprostol) or B (misoprotol and estrogen) are determined by a lot, Blinding description: This study is performed double-blind, the physician evaluating outcomes and the participants do not know the type of treatment. 3 Labor induction. Intervention 1: Intervention group: For termination of pregnancy, 25 micrograms of misoprostol is placed sublingual. According to the uterine contractions, every 3 to 6 hours, 25 micrograms of misoprostol is prescribed up to 4 times, or until the active phase of labor begins, or until the bishop score is 8 or higher, or until the rupture of membrane. In the first and second times of misoprostol administration, an applicator of Stromarin (estrogen) cream is also placed in the posterior part of the vagina. Intervention 2: Control group: For termination of pregnancy, 25 micrograms of misoprostol is placed sublingual. According to the uterine contractions, every 3 to 6 hours, 25 micrograms of misoprostol is prescribed up to 4 times, or until the active phase of labor begins, or until the bishop score is 8 or higher, or until the rupture of membrane. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified participants. When: After the manuscript is published. To whom: No limitations. Conditions: The data is only available to the project manager, Dr. Golshahi, and any analysis must be done with her opinion. Where to obtain: Dr. Golshahi. How to obtain: Any request must be sent by e-mail with its proposal to Dr. Golshahi. Comments:
public Fatemeh Golshahi
Yas hospital, North Nejatollahi St., Karimkhanzand Blvd.
Tehran Iran (Islamic Republic of) 1598718311 +98 21 4216 0852 fgolshahi@yahoo.com Tehran University of Medical Sciences scientific Fatemeh Golshahi
Yas hospital, North Nejatollahi St., Karimkhanzand Blvd.
Tehran Iran (Islamic Republic of) 1598718311 +98 21 4216 0852 fgolshahi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Term pregnancy (Gestational age >37 weeks) Nulliparous woman Singleton pregnancy Alive Fetus with cephalic presentation Bishop score < 5 no limit no limit Female Misoprostol or estrogen contraindication Women with a history the uterus surgery Women with a history or family history of thromboembolism O61.0 Failed medical induction of labor Treatment - Drugs Treatment - Drugs Intervention group: For termination of pregnancy, 25 micrograms of misoprostol is placed sublingual. According to the uterine contractions, every 3 to 6 hours, 25 micrograms of misoprostol is prescribed up to 4 times, or until the active phase of labor begins, or until the bishop score is 8 or higher, or until the rupture of membrane. In the first and second times of misoprostol administration, an applicator of Stromarin (estrogen) cream is also placed in the posterior part of the vagina. Control group: For termination of pregnancy, 25 micrograms of misoprostol is placed sublingual. According to the uterine contractions, every 3 to 6 hours, 25 micrograms of misoprostol is prescribed up to 4 times, or until the active phase of labor begins, or until the bishop score is 8 or higher, or until the rupture of membrane. Interval from induction with misoprostol to the attainment of 6 cm cervical dilation. Timepoint: Once, after delivery. Method of measurement: Information entered in the patient's delivery record. Interval from 6 cm cervical dilation to full cervical dilation. Timepoint: Once, after delivery. Method of measurement: Information entered in the patient's delivery record. Interval from full cervical dilation to active phase of labor. Timepoint: Once, after delivery. Method of measurement: Information entered in the patient's delivery record. Tehran University of Medical Sciences Approved 2023-06-11 Ethics committee of Tehran University of Medical Sciences Ethics committee of Tehran University of Medical Sciences, School of Medicine, Pour Sina St., Qods Ave. Tehran Tehran Iran (Islamic Republic of)