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

A

Ain Shams University

Status and phase

Completed
Phase 3

Conditions

Missed Abortion

Treatments

Drug: vaginal misoprostol
Drug: sublingual misoprostol

Study type

Interventional

Funder types

Other

Identifiers

NCT02686840
ASUMH

Details and patient eligibility

About

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

Full description

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.

Enrollment

200 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

sublingual misoprostol
Experimental group
Description:
Group A (100 patients): will be treated with sublingual misoprostol
Treatment:
Drug: sublingual misoprostol
vaginal misoprostol
Active Comparator group
Description:
Group B (100 patients): will be treated with vaginal misoprostol
Treatment:
Drug: vaginal misoprostol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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