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IRCT20201024049128N1 IRCT 2020-12-01 Karaj University of Medical Sciences Comparison of the Effectiveness of Intravaginal Misoprostol with Extra-Amniotic Saline Infusion in Labor Induction A Comparative Study about Maternal and Neonatal Outcomes of Using Extra-Amniotic Saline Infusion and vaginal Misoprostol for Cervical Ripening and Labor Induction in Pregnant Women with Unfavorable Cervix 2020-11-10 anticipated 144 Complete https://irct.ir/trial/51808 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Women who consented to participate were randomly selected to receive either Misoprostol or Extra-amniotic Saline Infusion. Group assignment was determined from a computer-generated table of random numbers.Some opaque envelopes were used for concealment. 4 Unfavorable cervix. Intervention 1: Intervention group: Vaginal Misoprostol. Misoprostol is a prostaglandin E1 analog known to stimulate uterine contractions. In this study 100-microgram tablets were used. In this intervention group, 25 micrograms of misoprostol (1/4 of 100-microgram tablet) was inserted intravaginally in the posterior fornix every 4 hours up to 5 doses. The maximal cervical ripening period until labor induced was 24 hours, regardless of the number of doses received. Intravenous oxytocin was given to the misoprostol group for the following reasons:(1) active labor did not occur after the maximum number of doses of misoprostol had been given, (2) spontaneous rupture of the membranes occurred without anadequate contraction pattern, or (3) dilation was arrested (no change in cervical dilation for >2 hours). Intervention 2: Intervention group: Extra-amniotic saline infusion. Saline is a type of isotonic solution and a mixture of salt and water. The concentration is 9 grams per litre (0.9% saline) . In this group, women underwent a speculum examination. After preparation of the cervix with Betadine solution, an18-gauge Foley catheter balloon was inserted to above the internal cervical os. The balloon was inflated to 30 milliliters with sterile normal saline solution, the Foley catheter was taped to the inner aspect of the subject’s thigh without any traction. A normal saline solution infusion of 30 mL per hour through the central lumen of the Foley catheter was initiated concurrently with intravenous oxytocin. Oxytocin infusion was started at a rate of 1.0 milliunits per minutes and was increased in nine stepwise increments to a maximum of 22.0 milliunits per minutes at 30-minute intervals as needed to achieve an adequate contraction pattern. The Foley catheter was removed for the following reasons: (1) 12 hours had elapsed since the initial placement (2) spontaneous rupture of membranes occurred, (3) evidence of fetal distress was noted, (4) the catheter was expelled spontaneously, or (5) the patient could no longer tolerate the procedure. 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 No more information
public Bita Badehnoosh
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street
Karaj Iran (Islamic Republic of) 3149779453 +98 26 3222 2021 b_badehnoosh@yahoo.com Karaj University of Medical Sciences scientific Bita badehnoosh
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street
Karaj Iran (Islamic Republic of) 3149779453 +98 26 3222 2021 b_badehnoosh@yahoo.com Karaj University of Medical Sciences Iran (Islamic Republic of) Singleton gestation Alive fetus Cephalic presentation Intact membranes Unfavorable cervix (Bishopscore ≤6) Reassuring fetal heart rate Gestational age≥28 no limit no limit Female Non-cephalic presentation Adequate uterine contractions (3 contractions Lasting for 30sec/10 min) Ruptured membranes Cephalopelvic disproportion Multiple pregnancy Polyhydramnios Estimated fetal weight ≥4000g or ≤1800g Placental abruption, Placenta previa Unexplained vaginal bleeding Prior lower segment cesarean section/Scarred uterus Non-reassuring fetal status Clinically detected vaginal infections(exp:genital herpes) or chorioamnionitis Latex or Prostaglandins allergy or any contraindications receiving Prostaglandins, including a history of asthma, glaucoma, or cardiovascular disease Intrauterine fetal death Renal or hepatic failure Treatment - Drugs Treatment - Devices Intervention group: Vaginal Misoprostol. Misoprostol is a prostaglandin E1 analog known to stimulate uterine contractions. In this study 100-microgram tablets were used. In this intervention group, 25 micrograms of misoprostol (1/4 of 100-microgram tablet) was inserted intravaginally in the posterior fornix every 4 hours up to 5 doses. The maximal cervical ripening period until labor induced was 24 hours, regardless of the number of doses received. Intravenous oxytocin was given to the misoprostol group for the following reasons:(1) active labor did not occur after the maximum number of doses of misoprostol had been given, (2) spontaneous rupture of the membranes occurred without anadequate contraction pattern, or (3) dilation was arrested (no change in cervical dilation for >2 hours) Intervention group: Extra-amniotic saline infusion. Saline is a type of isotonic solution and a mixture of salt and water. The concentration is 9 grams per litre (0.9% saline) . In this group, women underwent a speculum examination. After preparation of the cervix with Betadine solution, an18-gauge Foley catheter balloon was inserted to above the internal cervical os. The balloon was inflated to 30 milliliters with sterile normal saline solution, the Foley catheter was taped to the inner aspect of the subject’s thigh without any traction. A normal saline solution infusion of 30 mL per hour through the central lumen of the Foley catheter was initiated concurrently with intravenous oxytocin. Oxytocin infusion was started at a rate of 1.0 milliunits per minutes and was increased in nine stepwise increments to a maximum of 22.0 milliunits per minutes at 30-minute intervals as needed to achieve an adequate contraction pattern. The Foley catheter was removed for the following reasons: (1) 12 hours had elapsed since the initial placement (2) spontaneous rupture of membranes occurred, (3) evidence of fetal distress was noted, (4) the catheter was expelled spontaneously, or (5) the patient could no longer tolerate the procedure. The mean time interval from start of induction to delivery. Timepoint: Time of birth. Method of measurement: Clock. Duration of latent phase. Timepoint: At the end of latent phase. Method of measurement: Clock. Duration of active phase. Timepoint: At the end of active phase. Method of measurement: clock. Rate of delivery within 12 hours. Timepoint: At the end of study. Method of measurement: Patient's file. Rate of delivery within 24 hours. Timepoint: At the end of study. Method of measurement: Patient's file. Cesarean rate. Timepoint: At the end of study. Method of measurement: Patient's file. Incidence of tachysystole. Timepoint: Continuously. Method of measurement: Cardiotocography. Incidence of hypertonus. Timepoint: Continuously. Method of measurement: Cardiotocography. Apgar score. Timepoint: 1 minute and 5 minutes after birth. Method of measurement: Examination of the newborn. Incidence of meconium passage. Timepoint: At birth. Method of measurement: Examination of the newborn. Incidence of chorioamnionitis. Timepoint: Every 3 hours. Method of measurement: Physical examination. Karaj University of Medical Sciences Approved 2020-10-10 Ethics committee of Alborz University of Medical Sciences Ethics committee unit; Vice Chancellor for Research; No.20; Saffarian alley; 45 Metri Golshahr street Karaj Alborz Iran (Islamic Republic of)