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IRCT20200421047152N4 IRCT 2023-10-11 Iran University of Medical Sciences Safety and efficacy of cervical administration of misoprostol in induction of labor compared to vaginal and sublingual administration Safety and efficacy of cervical administration of misoprostol in induction of labor in mothers with unripe cervix and term pregnancy compared to vaginal and sublingual administration: a randomized clinical trial. 2023-10-17 anticipated 123 Complete https://irct.ir/trial/67578 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The candidates will be allocated into groups in a stratified randomization method (based on the history of parity) with a permutation block of 6 using a randomization list generated by the Sealedenvelope.com website software. The randomly generated sequence will be placed one by one in opaque closed envelopes and after writing the codes on it, it will be given to the third person in the delivery block, and will be opened after the entry of each volunteer and the group of that person will be specified, Blinding description: Study outcomes will be assessed by someone other than the intervention assignor. The information of the three groups will be provided to the statistical analyst in coded form so that they are not aware of the intervention groups. 3 Labour induction. Intervention 1: Intervention group with intracervical misoprostol: In this group, 25 micrograms of intracervical misoprostol is prescribed to induce labor. If appropriate contractions are not reached, misoprostol is repeated with the same dose every four hours. This process continues until at least three contractions with adequate strength with a duration between 40-60 seconds occur within ten minutes or four doses of misoprostol are repeated. Intervention 2: Intervention group: Intervention group with sublingual misoprostol: In this group, 25 micrograms of sublingual misoprostol is prescribed to induce labor. If appropriate contractions are not reached, misoprostol is repeated with the same dose every four hours. This process continues until at least three contractions with adequate strength with a duration between 40-60 seconds occur within ten minutes or four doses of misoprostol are repeated. Intervention 3: Intervention group: Intervention group with vaginal misoprostol: In this group, 25 micrograms of vagianl misoprostol is prescribed to induce labor. If appropriate contractions are not reached, misoprostol is repeated with the same dose every four hours. This process continues until at least three contractions with adequate strength with a duration between 40-60 seconds occur within ten minutes or four doses of misoprostol are repeated. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Data are in property of the university.
public Nooshin Eshraghi
Bagh ferdous station, Molavi St.
Tehran Iran (Islamic Republic of) 1168743514 +98 21 5560 6034 eshraghi.n@iums.ac.ir Iran University of Medical Sciences scientific Nooshin Eshraghi
Bagh ferdous station, Molavi St.
Tehran Iran (Islamic Republic of) 1168743514 +98 21 5560 6034 eshraghi.n@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Women aged 18-40 years Singleton pregnancy Cephalic presentation Gestational age more than 37 weeks Appropriate pelvic examination Intact membranes Fetal weight between 90-10th percentile estimated by ultrasound ishop score less than or equal to 6 18 years 40 years Female Birth history equal to or more than 3 Blood pressure equal to or greater than 140/90 mmHg Proteinuria or preeclampsia Getational diabetes Unreliability of fetal heart trace or any fetal distress Polyhydramnios or oligohydramnios The possibility of fetal macrosomia Intrauterine fetal death Previous history of uterine surgery Bleeding Placenta previa O61 Failed induction of labour Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group with intracervical misoprostol: In this group, 25 micrograms of intracervical misoprostol is prescribed to induce labor. If appropriate contractions are not reached, misoprostol is repeated with the same dose every four hours. This process continues until at least three contractions with adequate strength with a duration between 40-60 seconds occur within ten minutes or four doses of misoprostol are repeated. Intervention group: Intervention group with sublingual misoprostol: In this group, 25 micrograms of sublingual misoprostol is prescribed to induce labor. If appropriate contractions are not reached, misoprostol is repeated with the same dose every four hours. This process continues until at least three contractions with adequate strength with a duration between 40-60 seconds occur within ten minutes or four doses of misoprostol are repeated. Intervention group: Intervention group with vaginal misoprostol: In this group, 25 micrograms of vagianl misoprostol is prescribed to induce labor. If appropriate contractions are not reached, misoprostol is repeated with the same dose every four hours. This process continues until at least three contractions with adequate strength with a duration between 40-60 seconds occur within ten minutes or four doses of misoprostol are repeated. Time to reach active labour phase. Timepoint: Immediately after intervention. Method of measurement: Physical examination. Time to delivery. Timepoint: Between intervention and delivery. Method of measurement: Clinical examination. Percentage of cesarean section. Timepoint: 24 hours after intervention. Method of measurement: Clinical assessment. Neonatal apgar. Timepoint: First and fifth minutes after delivery. Method of measurement: clinical assessment. Iran University of Medical Sciences Approved 2022-11-23 IUMS Biomedical Research Ethics Committee Next to Milad Tower, Hemmat Tehran Tehran Iran (Islamic Republic of)