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Completed

NCT Number: NCT04788108

Oral Progesterone for Prevention of Miscarriage in Threatened Abortion

This study evaluates the effectiveness of oral dydrogesterone in preventing miscarriage in threatened abortion. Half of participants will receive oral dydrogesterone, while the other half will receive oral placebo.

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Key information

Conditions

Threatened Abortion Abortion, Threatened Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • singleton pregnancy with gestational age 6 - 20 weeks
  • threatened abortion
  • confirmed intrauterine pregnancy with a viable fetus by ultrasound

Exclusion criteria

  • history of recurrent miscarriage
  • having endocervical polyp
  • having infection such as pneumonia, pyelonephritis, septicemia
  • having autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis
  • having cancer
  • having coagulation defect
  • allergy to dydrogesterone

Treatment and study plan

Dydrogesterone

Drug

Dydrogesterone tablet

Placebo

Drug

Placebo tablet

Primary outcomes

  1. continue pregnancy more than 20 weeks gestation

    Time frame: at 20 weeks gestation

    percentage of cases with continue pregnancy more than 20 weeks gestation

Secondary outcomes

  1. preterm delivery less than 34 weeks

    Time frame: at 34 weeks gestation

    percentage of delivery less than 34 weeks

  2. preterm delivery less than 37 weeks

    Time frame: at 37 weeks gestation

    percentage of delivery less than 37 weeks

  3. placenta previa

    Time frame: 31 weeks

    percentage of placenta previa

  4. abruptio placenta

    Time frame: 31 weeks

    percentage of abruptio placenta

  5. Intrauterine growth restriction

    Time frame: 31 weeks

    percentage of intrauterine growth restriction

  6. neonatal complications

    Time frame: 31 weeks

    percentage of newborn with respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, death

  7. side effects

    Time frame: 6 weeks

    percentage of side effects such as headache, nausea/vomiting

  8. compliance

    Time frame: 6 weeks

    percentage of complete drug use

  9. maternal satisfaction

    Time frame: 6 weeks

    percentage of good satisfaction

  10. time until bleeding stops

    Time frame: 6 weeks

    time from first bleeding until bleeding stops

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

Oral Progesterone for Prevention of Miscarriage in Threatened Abortion: a Randomized, Double-blinded, Placebo-controlled Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 9, 2021
Registry last updated
Aug 30, 2023

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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