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NCT Number: NCT02686840

Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage

The aim of this work is to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first trimester missed miscarriage.

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Key information

Conditions

Missed Abortion Abortion, Missed Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ain shams university maternity hospital

Cairo, 25187, Egypt

About this study

In women with first trimetric-missed miscarriage, sublingual misoprostol may be as vaginal misoprostol in achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first trimester missed miscarriage.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All women above 18 years of age
  • Less than 12 weeks of gestation.
  • Pregnancy is confirmed by pregnancy test or ultrasound scan.
  • missed abortion
  • Normal general and gynecological examination.
  • The size of the uterus on pelvic examination was compatible with the estimated duration of pregnancy

Exclusion criteria

  • Hemodynamically unstable.
  • Suspected sepsis with temperature 38 °C.
  • Concurrent medical illness e.g. hematological, cardiovascular, thromboembolism, respiratory illnesses, recent liver disease or pruritus of pregnancy.
  • Presence of intrauterine contraceptive device (IUCD).
  • Suspect or proven ectopic pregnancy.
  • Failed medical or surgical evacuation before presentation.
  • Known allergy to misoprostol.

Treatment and study plan

Sublingual misoprostol

Drug

All patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of second dose will be given upon sending home.

  • Two doses of misoprostol 800 mcg each (four tablets of 200 mcg per dose).
  • Paracetamol, eight hourly, will be provided as analgesic or antipyretic.
  • A specimen bottle to collect the POC if passed out.
  • Two pairs of disposable gloves.
  • Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception

Other names: Misotac

Vaginal Misoprostol

Drug

All patients will receive three doses of vaginal misoprostol every four hours The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of second dose will be given upon sending home.

Paracetamol, eight hourly, will be provided as analgesic or antipyretic

Other names: Misotac

Primary outcomes

  1. Completeness of abortion: expulsion of Products of conception (POC)x by visual inspection

    Time frame: 7 days

Secondary outcomes

  1. Successful medical abortion: cervical os is closed with endometrial thickness of less than 15 mm

    Time frame: 7 days

  2. Failure: endometrial thickness of more than 15 mm on day seven (from third dose of misoprostol) or developing of complications before day seven needing early surgical evacuation.

    Time frame: 7 days

  3. Bleeding pattern following treatment

    Time frame: 7 days

    This will be assessed by hemoglobin(g/dl) and haematocrit level after the treatment , if the patients required blood transfusion and number of units transfused and number of days of bleeding

  4. Pain resulting from the procedure

    Time frame: 7 days

    this will be assessed by the doses of paracetamol given in mg

  5. Additional uterotonic used

    Time frame: 7 days

    additional misoprostol doses in mcg

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage: A Randomized Controlled Trial.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 22, 2016
Registry last updated
Aug 16, 2017

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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