Progestrone and Doppler Indices

NCT ID: NCT03292939

Last Updated: 2017-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2017-10-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Preterm Labor

Keywords

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progestrone doppler indices

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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vaginal progestrone group

cohort of patients who received 400mg vaginal progestrone .

Group Type OTHER

A complete Doppler flow assessment of the maternal and fetal circulation

Intervention Type 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.

Interventions

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A complete Doppler flow assessment of the maternal and fetal circulation

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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sarah mohamed hassan

lecturer of obstetrics and gynecology Cairo university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kasr El Ainiy Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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7880

Identifier Type: -

Identifier Source: org_study_id