Progestrone and Doppler Indices

Kasr El Aini Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Preterm Labor

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03292939

7880

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

80 participants in 1 patient group

vaginal progestrone group

Other group

Description:

cohort of patients who received 400mg vaginal progestrone .

Treatment:

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