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Completed

NCT Number: NCT03148314

Vaginal Misoprostol In Management Of First Trimester Missed Abortion.

The world health organization defined abortion or miscarriage as : the expulsion or extraction from its mother of a fetus or an embryo weighting 500 grams or less ,or any other wise product of gestation of any weight irrespective of gestational age and weather or not there is evidence of life and weather or not the abortion was spontaneous or induced Miscarriage is the most common complication of pregnancy occurring in 10-20% of clinically recognized pregnancies (Bag. It is estimated that around 40% of early pregnancies result in miscarriage. A large majority of those are lost before the menstrual period is missed. More than 80%of abortions occur in first 12 weeks of pregnancy, and the rate decrease there after For clinical purposes: abortion is subdivided into: threatened abortion, inevitable abortion, incomplete abortion ,missed abortion ,septic abortion ,and recurrent abortion

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Key information

Conditions

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

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • single dead fetus up-to 12 weeks.
  • no low lying placenta
  • no scarred uterus
  • no or mild bleeding
  • no evidence of infection
  • accepting to participate in the study.

Exclusion criteria

  • Advanced hepatic diseases .
  • Suspected molar pregnancy
  • Ectopic pregnancy or pregnancy of unknown location
  • Haemodynamically unstable with significant anaemia ie Hb<10
  • Uncontrolled severe asthma
  • Chronic adrenal failure
  • Known or suspected heart disease
  • Glaucoma
  • Haemoglobinopathies
  • Haemorrhagic disorders and anti-coagulation therapy (aspirin accepted)
  • Adrenal suppression and long term glucocorticoid therapy (may require corticosteroid)
  • Patient living in remote areas with difficulty in accessing hospital

Treatment and study plan

Vaginal Misoprostol

Drug

(800µgm.x 2 doses 3 hours).

Other names: buccal/sublingual misoprostol

buccal/sublingual misoprostol

Drug

200 µgm.x4 hrs.x 6 doses

Other names: vaginal misoprostol

Primary outcomes

  1. Percentage of patients with complete abortion (success rate).

    Time frame: 1 week

Secondary outcomes

  1. Number of misoprostol doses

    Time frame: 1 week

  2. induction-abortion time

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Home-Based Extended Low Dose Buccal Misoprostol Versus Hospital-Based Standard Vaginal Dose In Management Of First Trimester Missed Abortion.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 11, 2017
Registry last updated
Apr 24, 2024

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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