A randomized trial comparing prostaglandin E2 vaginal insert (Cervidil) to vaginal gel for cervical ripening before induction of labor |
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| Affiliation: | 1. Department of Obstetrics and Gynaecology, University of British Columbia, Vancouver BC;2. Child and Family Research Institute, University of British Columbia, Vancouver BC;3. Children''s and Women''s Health Centre of British Columbia, Vancouver BC;4. Department of Pediatrics, University of British Columbia, Vancouver BC;5. Department of Medicine, University of British Columbia, Vancouver BC;6. Department of Medicine, British Columbia Women''s Hospital and Health Centre, Vancouver BC;1. Department of Medicine, University of Auckland, Auckland, New Zealand;2. Department of Endocrinology, ADHB, Auckland, New Zealand;3. Health Services Research Unit, University of Aberdeen, Aberdeen, Scotland;1. Department of Obstetrics and Gynecology, Columbia University Irving Medical Center, New York, NY, USA;2. Division of Gynecologic Specialty Surgery, Department of Obstetrics and Gynecology Columbia University''s Vagelos College of Physicians and Surgeons, NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, NY, USA;3. Department of Obstetrics and Gynecology, Columbia University''s Vagelos College of Physicians and Surgeons NewYork-Presbyterian Hospital/Lawrence Hospital, Bronxville, NY, USA;4. Division of Family Planning & Preventive Service, Department of Obstetrics and Gynecology Columbia University''s Vagelos College of Physicians and Surgeons NewYork-Presbyterian Hospital/Columbia University Irving Medical Center New York, NY, USA;5. Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology Columbia University''s Vagelos College of Physicians and Surgeons NewYork-Presbyterian Hospital/Columbia University Irving Medical Center New York, NY, USA;6. Division of Gynecologic Oncology Department of Obstetrics and Gynecology Columbia, University''s Vagelos College of Physicians and Surgeons NewYork-Presbyterian Hospital/Columbia University Irving Medical Center New York, NY, USA;7. Division of Maternal Fetal Medicine Department of Obstetrics and Gynecology, Columbia University''s Vagelos College of Physicians and Surgeons NewYork-Presbyterian Hospital/Columbia University Irving Medical Center NY Bronxville, NY, USA |
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| Abstract: | ![]()
Objective: To compare the efficacy and safety of a controlled release vaginal insert (Cervidil) with hospital compounded prostaglandin E2 vaginal gel for cervical ripening before labor induction.Methods: A prospective randomized study was performed between July 1996 and August 1997 on 200 patients undergoing cervical ripening before induction of labor. The efficacy and safety of a 12-hour controlled release 10-mg vaginal insert (Cervidil, Forest Pharmaceuticals) was compared with two 4-mg doses of prostaglandin E2 gel.Results: The study groups did not differ by parity, estimated gestational age, indications for induction, and initial Bishop scores. No differences were noted in Bishop score at 12 hours or change in Bishop score. No statistically significant differences were noted in the successful inductions, additional days of induction, and the number of patients discharged undelivered. There were no differences in mean time to active labor, cesarean section, meconium staining, 1 and 5 minute Apgar scores, cord pH values, NICU admissions, and incidence of hyperstimulation. | Empty Cell | Cervidil (n = 88) | Pg E2 gel (n = 88) | Empty Cell |
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| Initial Bishop score (mean) | 3.0 | 3.1 | NS | | 12-h Bishop score (mean) | 8.5 | 9.1 | NS | | Change in Bishop score 0–12 h (mean) | 5.8 | 6.0 | NS | | Successful inductions | 71 (80.7%) | 77 (87.5%) | NS | | Additional days of induction | 27 | 20 | NS | | Patients discharged undelivered | 5 (5.7%) | 6 (6.8%) | NS | | Hyperstimulation | 5 (5.7%) | 4 (4.5%) | NS |
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