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Completed

NCT Number: NCT02048098

Misoprostol for Second Trimester Termination of Pregnancy

The purpose of this study is to compare the efficacy of 400 µg vaginal misoprostol per 3 hours to 400 µg buccal misoprostol per 3 hours in second trimester termination of viable pregnancy

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Key information

Conditions

Abortion, Induced Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

16 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ataturk Universitesi Araştırma Hastanesi

Erzurum, 25240, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • gestational age between 12-24 weeks
  • live fetus
  • singleton pregnancy
  • Bishop score <5
  • no uterine contraction

Exclusion criteria

  • prostaglandin allergy
  • a scar in uterus
  • uterine abnormality
  • premature rupture of membranes

Treatment and study plan

Vaginal Misoprostol

Drug

400 µg vaginal misoprostol per 3 hours up to 6 doses. The treatment will be withold if the patient has strong uterine contractions. If abortion had not occured in 24 hour after the start of the study a second course of 400 µg vaginal misoprostol per 3 hours up to 6 doses will be administered. If abortion had not occured in 48 hour after the start of the study it will be considered treatment failure and patient will be offered another induction/delivery method or to continue protocol.

Other names: Cytotec

Buccal Misoprostol

Drug

400 µg buccal misoprostol per 3 hours up to 6 doses. The treatment will be withold if the patient has strong uterine contractions. If abortion had not occured in 24 hour after the start of the study a second course of 400 µg buccal misoprostol per 3 hours up to 6 doses will be administered. If abortion had not occured in 48 hour after the start of the study it will be considered treatment failure and patient will be offered another induction/delivery method or to continue protocol.

Other names: Cytotec

Primary outcomes

  1. Induction to fetal expulsion interval

    Time frame: 15 minutes after fetus delivered

    Time elapsed between administration of the first misoprostol dose until expulsion of the fetus

Secondary outcomes

  1. Delivery within 24 hours

    Time frame: 24 hour

  2. Delivery within 48 hours

    Time frame: 48 hours

  3. Use of additional interventions

    Time frame: One week

    the patients who did not delivered within 48 hours will considered as failed induction and will be offered another method of induction/delivery or to continue same protocol.

  4. Expected pain before induction and perceived (actual) pain after abortion completed

    Time frame: within 1 hour after randomisation and after 12 hour after complete abortion/placenta removed

    Expected and perceived pain will be measured by VAS

  5. Rate of complete abortion

    Time frame: 12 hour after fetus and placenta removed

Other outcomes

  1. total misoprostol dose

    Time frame: 48 hours

  2. difference in hematocrit measured at entry of the study and after delivery/abortion

    Time frame: at recruitment and 24 hour after abortion

  3. maternal complications

    Time frame: one weeks

    includes, but not limited blood, transfusions, laparatomy, nausea, vomiting, fever, genital tract injury

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

A Comparison Between Vaginal Misoprostol vs. Buccal Misoprostol For Second Trimester Termination of Pregnancy

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 29, 2014
Registry last updated
Jan 16, 2015

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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