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Completed

NCT Number: NCT00797693

Misoprostol in Termination of First Trimester Missed Abortion

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.

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Key information

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maternity Teaching Hospital

Erbil, Hawler, 964, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Misoprostol ( Cytotec) 200 microgram a tablet

Drug

In this study, two arms we put under study ... and to find how far a single drug, Misoprostol, is effective to have changes on the cervix.

Other names: PHARMACIA CORPORATION - Istanbul, serial number 022-00, 200 microgram a tablet

Primary outcomes

  1. Priming with misoprostol administered orally or vaginally three hours before surgical termination of first trimester missed abortion under general anesthesia facilitates cervical dilatation

    Time frame: 6 months

Secondary outcomes

  1. Higher patient satisfaction for self administered oral misoprostol at home

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Collaborators

  • HAWLER Maternity Hospital

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Nov 25, 2008
Registry last updated
Nov 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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