Progestrone and Doppler Indices

NCT03292939 | Completed Phase 2

• 1 other identifier: 7880
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Preterm Labor

Keywords

progestrone; doppler indices

Outcome Measures

Primary Outcomes (1)

• change of ultrasound doppler indices.

  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.

  before and 48 hours after progestrone admistration

Study Arms (1)

vaginal progestrone group

OTHER

cohort of patients who received 400mg vaginal progestrone .

Diagnostic Test: A complete Doppler flow assessment of the maternal and fetal circulation

Interventions

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.

vaginal progestrone group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr El Ainiy Hospital

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of obstetrics and gynecology Cairo university

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 26, 2017
• Study Start: January 1, 2017
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 11, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)