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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03292939
Other study ID # 7880
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received September 20, 2017
Last updated October 10, 2017
Start date January 1, 2017
Est. completion date October 1, 2017

Study information

Verified date October 2017
Source Kasr El Aini Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date October 1, 2017
Est. primary completion date October 1, 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
A complete Doppler ?ow assessment of the maternal and fetal circulation
A complete Doppler ?ow 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.

Locations

Country Name City State
Egypt Kasr El Ainiy Hospital Cairo

Sponsors (1)

Lead Sponsor Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary change of ultrasound doppler indices. A complete Doppler ?ow assessment of the maternaland fetal circulation was conducted by an independent investigator blinded to the treatment, before and 48 hours after the ?rst 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
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