Progestrone and Doppler Indices

Phase 2

Completed

• Conditions: Preterm Labor
• Interventions: Diagnostic Test: A complete Doppler flow assessment of the maternal and fetal circulation

• Registration Number: NCT03292939
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-09-20
• Study First Submitted QC: 2017-09-25
• Study First Posted: 2017-09-26
• Status Verified: 2017-10
• Primary Completion: 2017-10-01
• Study Completion: 2017-10-01
• Last Update Submitted: 2017-10-10
• Last Update Posted: 2017-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vaginal progestrone group	A complete Doppler flow assessment of the maternal and fetal circulation	cohort of patients who received 400mg vaginal progestrone .

Primary Outcome Measures

Name	Time	Method
change of ultrasound doppler indices.	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.

Trial Locations

Locations (1)

Kasr El Ainiy Hospital; 🇪🇬 Cairo, Egypt