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OpenTrials
Completed

NCT Number: NCT03930212

Progesterone Supplementation in Threatened Abortion

To decide whether progesterone supplementation in threatened abortion is a sound practice.

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Key information

Conditions

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

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ayman Shehata Dawood

Tanta, Egypt

About this study

This study was conducted at Obstetrics and Gynecology Department, Tanta University in the period from January 2018 to December 2018. Patients: Eligible patients (n=190) were randomly allocated into 2 groups; study group who will receive progesterone supplementation (Prog.group) and control group who will receive no treatment (place.group).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • threatened abortion diagnosed by history and ultrasound examination
  • singleton
  • viable fetus
  • gestational age < 20 weeks
  • closed normal length cervix.

Exclusion criteria

  • short cervix <2 cm Multiple pregnancy
  • dead fetus
  • open cervix ≥ 2cm
  • history of cervical surgery
  • refusal to participate.

Treatment and study plan

Progesterone

Drug

received rectal progesterone suppositories 400 mg once daily

Placebos

Drug

received placebo suppositories rectally once daily.

Primary outcomes

  1. relief of pain

    Time frame: 3 weeks

    questionnaire fulfilled by patient with yes or no questions

  2. completion of pregnancy beyond 20 weeks

    Time frame: 12 weeks

    passing the age 20 weeks

  3. Stoppage of bleeding

    Time frame: 3 weeks

    Cessation of bleeding

Secondary outcomes

  1. abortion less than 20 weeks.

    Time frame: 12 weeks

    Abortion

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Progesterone Supplementation in Threatened Abortion: Is it a Sound Practice?

Acronym: Prothreat

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 29, 2019
Registry last updated
Jul 18, 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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