Clinical trial NCT00797693: Misoprostol in Termination of First Trimester Missed Abortion
Official title: Oral Versus Vaginal Misoprostol as Cervical Ripening Agent Prior to Surgical Termination of First Trimester Missed Abortions in Hawler Maternity Teaching Hospital in Erbil/Iraq
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Miscarriage
Keywords: First trimester
missed abortion
misoprostol
cervical ripening
oral
vaginal
first trimester missed abortion
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
Collaborators: name: HAWLER Maternity Hospital
First posted: 2008-11-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether oral versus vaginal misoprostol is effective in termination of first trimester missed abortion and to compare between two different routes.

Detailed description: Objective: To compare the effectiveness of oral versus vaginal misoprostol prior to surgical termination of first trimester missed abortion as cervical priming agent , the difference of cervical dilatation immediately prior to operation , the duration of operation and side effects between two treatment groups.

Design: This study was conducted as randomised study.

Setting: Maternity Teaching Hospital in Hawler/ Kurdistan/ Iraq.

Population: Over a period of six months from the first of January to the thirtieth of June, 2008, one hundred women were included in this study. They were cases of first trimester abortion (6-12 weeks).

Method: Patients were randomly selected for the type of treatment they received. The first group (oral) were assigned to receive 400 micrograms of misoprostol orally as preoperative cervical priming agent, where as the second group (vaginal) were allocated to have treatment either with vaginal misoprostol to receive 400 micrograms vaginally.

Main outcome measure: Oral versus vaginal misoprostol as cervical ripening agent prior to termination of first trimester missed abortion.

Keywords: First trimester, missed abortion, misoprostol, cervical ripening, oral, vaginal.

Eligibility criteria: Inclusion Criteria:

* All patients were cases of first trimester missed abortion.
* They have uneventful history apart from history of slight vaginal bleeding, with normal general examination. Gynecological examination revealed no vaginal bleeding or discharge with no dilatation of the internal os with enlarged uterus.

Exclusion Criteria:

* Cases with suspected or proven ectopic pregnancy, history of Caesarean section, medical diseases, a known hypersensitivity to a drug, smokers, patients with abnormal results of investigation and the presence of vaginal bleeding were excluded from the study.

Primary outcomes:
measure: Priming with misoprostol administered orally or vaginally three hours before surgical termination of first trimester missed abortion under general anesthesia facilitates cervical dilatation
timeFrame: 6 months
Secondary outcomes:
measure: Higher patient satisfaction for self administered oral misoprostol at home
timeFrame: 6 months
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Maternity Teaching Hospital
state: Hawler
Study officials:
References: