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Completed

NCT Number: NCT03292939

Progestrone and Doppler Indices

The aim of our study is to assess the effect of vaginal progestrone on fetal and maternal doppler indices

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Key information

Conditions

Preterm Labor Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Kasr El Ainiy Hospital

Cairo, 11562, Egypt

About this study

A complete Doppler flow assessment of the maternal and fetal circulation was conducted by an independent investigator blinded to the treatment, before and 48 hours after the first administration of 400mg of vaginal progesterone, Voluson E8 (GE Healthcare, Zipf, Austria) ultrasound machine,equipped with a 3.5- MHz curvilinear abdominal transducer with color imaging capabilities, was used in all cases.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Gestational age: 18-33 weeks
  • Willing and able to give informed consent
  • History of preterm labor (<34 weeks)
  • At risk for preterm labor ( increased amniotic fluid volume)
  • Short cervical length (<25mm) as incidental finding
  • Presenting with actual cervical changes ( dilatation and\\or effacement) in current pregnancy

Exclusion criteria

  • PPROM
  • Contraindication to progesterone use
  • Diabetic patients, have glucose intolerance
  • Multiple pregnancies

Treatment and study plan

A complete Doppler flow assessment of the maternal and fetal circulation

Diagnostic Test

A complete Doppler flow assessment of the maternal and fetal circulation was conducted by an independent investigator blinded to the treatment, 48 hours after receiving 400mg of vaginal progestrone .Voluson E8 (GE Healthcare, Zipf, Austria) ultrasound machine ,equipped with a 3.5-MHz curvilinear abdominal transducer with color imaging capabilities, was used in all cases.

Primary outcomes

  1. change of ultrasound doppler indices.

    Time frame: before and 48 hours after progestrone admistration

    A complete Doppler flow assessment of the maternaland fetal circulation was conducted by an independent investigator blinded to the treatment, before and 48 hours after the first administration of progesterone, Voluson E8 (GE Healthcare, Zipf, Austria) ultrasoundmachine,equippedwitha3.5-MHzcurvilinearabdominaltransducer with color imaging capabilities, was used in all cases.

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

The Effect of Vaginal Progestrone on Fetal and Maternal Doppler Indices

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 26, 2017
Registry last updated
Oct 11, 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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