Progestrone and Doppler Indices

Preterm Labor Clinical Trial

Official title:

The Effect of Vaginal Progestrone on Fetal and Maternal Doppler Indices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03292939
• Other study ID #: 7880
• 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
• 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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Preterm Labor

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