Extra-Amniotic Normal Saline Infusion plus Hydrocortisone versus Prostaglandin E2 Suppository for Pregnancy Termination

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2011
INTERVENTION: In EASHI group (25 patients), under sterile conditions, a coworker inserted a No. 14 Foley catheter through the cervical canal and balloon was filled with 20 ml water and fixed. Then 360 ml sterile Normal Saline with 100 mg. Hydrocortisone was infused at a rate of 30 ml per hours into the extra amniotic space. The Foley catheter was checked every hour for spontaneous expulsion. If it was tolerated by patients, the infusion continued up to 12 hours maximum. In both groups, 6 hours after the last dose of prostaglandin and removal of Foley catheter, induction with high dose Oxytocin (according to Alabama University Protocol) was initiated up to 24 hours maximum. Intervention 1: Prostaglandin group (25 patients) was received two doses of prostaglandin E2 intra vaginal suppository (Dinoprostone) 3mg every 4 hour. In both groups, 6 hours after the last dose of prostaglandin and removal of Foley catheter, induction with high dose Oxytocin (according to Alabama University Protocol) was initiated up to 24 hours maximum. Intervention 2: In EASHI group (25 patients), under sterile conditions, a coworker inserted a No. 14 Foley catheter through the cervical canal and balloon was filled with 20 ml water and fixed. Then 360 ml sterile Normal Saline with 100 mg. Hydrocortisone was infused at a rate of 30 ml per hours into the extra amniotic space. The Foley catheter was checked every hour for spontaneous expulsion. If it was tolerated by patients, the infusion continued up to 12 hours maximum. In both groups, 6 hours after the last dose of prostaglandin and removal of Foley catheter, induction with high dose Oxytocin (according to Alabama University Protocol) was initiated up to 24 hours maximum. Prostaglandin group (25 patients) was received two doses of prostaglandin E2 intra vaginal suppository (Dinoprostone) 3mg every 4 hour. In both groups, 6 hours after the last dose of prostaglandin and removal of Foley catheter, induction with high dose Oxytocin (according to Alabama University Protocol) was initiated up to 24 hours maximum. Treatment ‐ Drugs CONDITION: Induction of labor, termination of pregnancy. ; Medical abortion: Incl: termination of pregnancy: legal Medical abortion: Incl: termination of pregnancy: legal PRIMARY OUTCOME: Mean time from initiation of induction till expultion of conception. Timepoint: Hour. Method of measurement: Excretion products of pregnancy. INCLUSION CRITERIA: Inclusion criteria :Multiparus ?reater than or equal to 4; Bishop Score less than or equal to 2; Gestational age 14‐28 weeks; Amniotic sac intact; Fetal indication of Pregnancy Termination. Exclusion criteria : Placenta Previa; Uterus Anomalies; Rupture of Membrane; History of Hypertension; Fever; Cardiac Disease; Previous Scar on the Uterus; Drug Sensitivity (Prostaglandin E2 and Hydrocortisone); contraction of uterus. SECONDARY OUTCOME: Diarrhea. Timepoint: Every 4 hours. Method of measurement: The passage of three or more loose or watery stools a day. Fever. Timepoint: Every 4 hours. Method of measurement: Temperature above 38 ° C sublingual. Hypertension. Timepoint: Every 4 hours. Method of measurement: Blood pressure greater than or equal to 140/90 mm Hg. Hypotension. Timepoint: Every 4 hours. Method of measurement: Blood pressure less than 90/70 mm Hg. Nausea, vomiting. Timepoint: Every 4 hours. Method of measurement: Based on patient complaints and symptoms of disease by observing investigator. Placenta retention. Timepoint: Every 20 minutes. Method of measurement: Retention of placenta up to half an hour after expulsion of fetus. Success rate of pregnancy termination. Timepoint: hour. Method of measurement: Expultion of pregnancy conception. Tachy systole. Timepoint: Hour. Method of measurement: More than 6 uterine contractions in ten minutes. The need to curettage. Timepoint: 24 hours after fetus expultion. Method of measurement: Residual of conception based on ultrasonography. Uterus hyperton. Timepoint: Hour. Method of measurement: The Uterine contractions of more than two minutes.
Epistemonikos ID: 2f1dfeb9f93b7fbee58e36271d92b9beeabf1a24
First added on: Aug 22, 2024