Buccal misoprostol for treatment of fetal death at 14-28 weeks of pregnancy

A double-blind randomized controlled trial

Hillary Bracken, Nguyen Thi Nhu Ngoc, Erika Banks, Paul D. Blumenthal, Richard J. Derman, Ashlesha Patel, Marji Gold, Beverly Winikoff

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Objective To assess whether buccal misoprostol is effective for the treatment of intrauterine fetal death. Study Design This double-blind randomized trial was conducted at five tertiary-level hospitals in the United States and Vietnam. One hundred fifty-three women with an intrauterine fetal death at 14-28 weeks of pregnancy received either 100 mcg buccal misoprostol or 200 mcg buccal misoprostol every 6 h for a maximum of 8 doses. The main outcome measure was the fetal-placental delivery rate within 48 hours of prostaglandin commencement without any additional intervention. Results Most of the women (140/153) were recruited at the study site in Vietnam. Expulsion of both fetus and placenta within 48 hours of prostaglandin commencement without any additional interventions occurred in 61.8% (47/76) of women receiving misoprostol 100 mcg and 77.9% (60/77) of women receiving misoprostol 200 mcg. The 200 mcg dose was significantly more effective than the 100 mcg dose at expelling the fetus and placenta within 48 h [RR 0.68 (95% CI: 0.50-0.92; p=.03)]. The mean time to expulsion was significantly shorter using the 200 mcg dose (18.5±11.9 h) than the 100 mcg dose (23.9±12.5 h) (p=.02). Most women in both groups found the procedure satisfactory or very satisfactory (100 mcg: 76.7% (56/73); 200 mcg: 89.5% (68/76) [RR 0.86 (95% CI: 0.74-1.00)]. Conclusion Buccal misoprostol is an effective method for medical induction of labor after intrauterine fetal demise. A 200 mcg dose is significantly more effective than 100 mcg for evacuating the uterus within 48h. The treatment is highly acceptable to women. Implications Administration of 200 mcg buccal misoprostol every six hours is an effective and acceptable method to effect the delivery of a demised fetus at 14-28 weeks that can be feasibly implemented in a wide variety of settings.

Original languageEnglish (US)
Pages (from-to)187-192
Number of pages6
JournalContraception
Volume89
Issue number3
DOIs
StatePublished - 2014

Fingerprint

Misoprostol
Fetal Death
Cheek
Randomized Controlled Trials
Pregnancy
Fetus
Vietnam
Placenta
Therapeutics
Prostaglandins
Induced Labor
Tertiary Care Centers
Uterus
Outcome Assessment (Health Care)

Keywords

  • Buccal misoprostol
  • Intrauterine fetal demise

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

Cite this

Buccal misoprostol for treatment of fetal death at 14-28 weeks of pregnancy : A double-blind randomized controlled trial. / Bracken, Hillary; Ngoc, Nguyen Thi Nhu; Banks, Erika; Blumenthal, Paul D.; Derman, Richard J.; Patel, Ashlesha; Gold, Marji; Winikoff, Beverly.

In: Contraception, Vol. 89, No. 3, 2014, p. 187-192.

Research output: Contribution to journalArticle

Bracken, Hillary ; Ngoc, Nguyen Thi Nhu ; Banks, Erika ; Blumenthal, Paul D. ; Derman, Richard J. ; Patel, Ashlesha ; Gold, Marji ; Winikoff, Beverly. / Buccal misoprostol for treatment of fetal death at 14-28 weeks of pregnancy : A double-blind randomized controlled trial. In: Contraception. 2014 ; Vol. 89, No. 3. pp. 187-192.
@article{d24b98d397744247810aa0cd3bdd1e86,
title = "Buccal misoprostol for treatment of fetal death at 14-28 weeks of pregnancy: A double-blind randomized controlled trial",
abstract = "Objective To assess whether buccal misoprostol is effective for the treatment of intrauterine fetal death. Study Design This double-blind randomized trial was conducted at five tertiary-level hospitals in the United States and Vietnam. One hundred fifty-three women with an intrauterine fetal death at 14-28 weeks of pregnancy received either 100 mcg buccal misoprostol or 200 mcg buccal misoprostol every 6 h for a maximum of 8 doses. The main outcome measure was the fetal-placental delivery rate within 48 hours of prostaglandin commencement without any additional intervention. Results Most of the women (140/153) were recruited at the study site in Vietnam. Expulsion of both fetus and placenta within 48 hours of prostaglandin commencement without any additional interventions occurred in 61.8{\%} (47/76) of women receiving misoprostol 100 mcg and 77.9{\%} (60/77) of women receiving misoprostol 200 mcg. The 200 mcg dose was significantly more effective than the 100 mcg dose at expelling the fetus and placenta within 48 h [RR 0.68 (95{\%} CI: 0.50-0.92; p=.03)]. The mean time to expulsion was significantly shorter using the 200 mcg dose (18.5±11.9 h) than the 100 mcg dose (23.9±12.5 h) (p=.02). Most women in both groups found the procedure satisfactory or very satisfactory (100 mcg: 76.7{\%} (56/73); 200 mcg: 89.5{\%} (68/76) [RR 0.86 (95{\%} CI: 0.74-1.00)]. Conclusion Buccal misoprostol is an effective method for medical induction of labor after intrauterine fetal demise. A 200 mcg dose is significantly more effective than 100 mcg for evacuating the uterus within 48h. The treatment is highly acceptable to women. Implications Administration of 200 mcg buccal misoprostol every six hours is an effective and acceptable method to effect the delivery of a demised fetus at 14-28 weeks that can be feasibly implemented in a wide variety of settings.",
keywords = "Buccal misoprostol, Intrauterine fetal demise",
author = "Hillary Bracken and Ngoc, {Nguyen Thi Nhu} and Erika Banks and Blumenthal, {Paul D.} and Derman, {Richard J.} and Ashlesha Patel and Marji Gold and Beverly Winikoff",
year = "2014",
doi = "10.1016/j.contraception.2013.11.014",
language = "English (US)",
volume = "89",
pages = "187--192",
journal = "Contraception",
issn = "0010-7824",
publisher = "Elsevier USA",
number = "3",

}

TY - JOUR

T1 - Buccal misoprostol for treatment of fetal death at 14-28 weeks of pregnancy

T2 - A double-blind randomized controlled trial

AU - Bracken, Hillary

AU - Ngoc, Nguyen Thi Nhu

AU - Banks, Erika

AU - Blumenthal, Paul D.

AU - Derman, Richard J.

AU - Patel, Ashlesha

AU - Gold, Marji

AU - Winikoff, Beverly

PY - 2014

Y1 - 2014

N2 - Objective To assess whether buccal misoprostol is effective for the treatment of intrauterine fetal death. Study Design This double-blind randomized trial was conducted at five tertiary-level hospitals in the United States and Vietnam. One hundred fifty-three women with an intrauterine fetal death at 14-28 weeks of pregnancy received either 100 mcg buccal misoprostol or 200 mcg buccal misoprostol every 6 h for a maximum of 8 doses. The main outcome measure was the fetal-placental delivery rate within 48 hours of prostaglandin commencement without any additional intervention. Results Most of the women (140/153) were recruited at the study site in Vietnam. Expulsion of both fetus and placenta within 48 hours of prostaglandin commencement without any additional interventions occurred in 61.8% (47/76) of women receiving misoprostol 100 mcg and 77.9% (60/77) of women receiving misoprostol 200 mcg. The 200 mcg dose was significantly more effective than the 100 mcg dose at expelling the fetus and placenta within 48 h [RR 0.68 (95% CI: 0.50-0.92; p=.03)]. The mean time to expulsion was significantly shorter using the 200 mcg dose (18.5±11.9 h) than the 100 mcg dose (23.9±12.5 h) (p=.02). Most women in both groups found the procedure satisfactory or very satisfactory (100 mcg: 76.7% (56/73); 200 mcg: 89.5% (68/76) [RR 0.86 (95% CI: 0.74-1.00)]. Conclusion Buccal misoprostol is an effective method for medical induction of labor after intrauterine fetal demise. A 200 mcg dose is significantly more effective than 100 mcg for evacuating the uterus within 48h. The treatment is highly acceptable to women. Implications Administration of 200 mcg buccal misoprostol every six hours is an effective and acceptable method to effect the delivery of a demised fetus at 14-28 weeks that can be feasibly implemented in a wide variety of settings.

AB - Objective To assess whether buccal misoprostol is effective for the treatment of intrauterine fetal death. Study Design This double-blind randomized trial was conducted at five tertiary-level hospitals in the United States and Vietnam. One hundred fifty-three women with an intrauterine fetal death at 14-28 weeks of pregnancy received either 100 mcg buccal misoprostol or 200 mcg buccal misoprostol every 6 h for a maximum of 8 doses. The main outcome measure was the fetal-placental delivery rate within 48 hours of prostaglandin commencement without any additional intervention. Results Most of the women (140/153) were recruited at the study site in Vietnam. Expulsion of both fetus and placenta within 48 hours of prostaglandin commencement without any additional interventions occurred in 61.8% (47/76) of women receiving misoprostol 100 mcg and 77.9% (60/77) of women receiving misoprostol 200 mcg. The 200 mcg dose was significantly more effective than the 100 mcg dose at expelling the fetus and placenta within 48 h [RR 0.68 (95% CI: 0.50-0.92; p=.03)]. The mean time to expulsion was significantly shorter using the 200 mcg dose (18.5±11.9 h) than the 100 mcg dose (23.9±12.5 h) (p=.02). Most women in both groups found the procedure satisfactory or very satisfactory (100 mcg: 76.7% (56/73); 200 mcg: 89.5% (68/76) [RR 0.86 (95% CI: 0.74-1.00)]. Conclusion Buccal misoprostol is an effective method for medical induction of labor after intrauterine fetal demise. A 200 mcg dose is significantly more effective than 100 mcg for evacuating the uterus within 48h. The treatment is highly acceptable to women. Implications Administration of 200 mcg buccal misoprostol every six hours is an effective and acceptable method to effect the delivery of a demised fetus at 14-28 weeks that can be feasibly implemented in a wide variety of settings.

KW - Buccal misoprostol

KW - Intrauterine fetal demise

UR - http://www.scopus.com/inward/record.url?scp=84896546074&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84896546074&partnerID=8YFLogxK

U2 - 10.1016/j.contraception.2013.11.014

DO - 10.1016/j.contraception.2013.11.014

M3 - Article

VL - 89

SP - 187

EP - 192

JO - Contraception

JF - Contraception

SN - 0010-7824

IS - 3

ER -