Comparison Between Natural Progesterone and Vaginal Pessary for the Prevention of Spontaneous Preterm Birth

Premature Birth Clinical Trial

— PROPE  

Official title:

Comparison Between Natural Progesterone and Vaginal Pessary for the Prevention of Spontaneous Preterm Birth in Pregnant Women With a Uterine Cervix Measuring 25 mm or Less in Length

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02511574
• Other study ID #: 470.095
• Status: Recruiting
• Phase: Phase 4
• Start date: June 2014
• Est. completion date: December 2020

Study information

• Verified date: July 2018
• Source: University of Sao Paulo
• Contact: Mario Henrique B Carvalho
• Phone: +55 11 26616380
• Email: marioburlacchini[@]uol.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the effectiveness between the cervical pessary and the natural progesterone in reduction of preterm birth rates in pregnant women with a uterine cervical length of 25 mm or less evaluated by transvaginal ultrasonography.

Description:

Preterm birth is the leading cause of perinatal morbidity and mortality. The rates of spontaneous premature labor have not changed much during the past 10 years. A significant decrease in mortality and morbidity of premature babies will only be possible if women at risk of spontaneous preterm birth are accurately identified and administered preventive therapies. Ultrasonographic measurement of the cervix between 20 and 24 weeks of gestation can improve the identification of both women with single pregnancies and those with twin pregnancies at risk. Asymptomatic women with a short uterine cervix (25 mm or less) are at increased risk of spontaneous premature labor.

The prophylactic use of progesterone during the early phase of pregnancy in women with a history of preterm birth and those with a short cervix can prevent preterm birth.

The cervical pessary is a device used also for the prevention of preterm birth. The omega-3 intake also appears to be related to the prevention of prematurity. Vaginal infections are also important causes of preterm birth. There are not many studies about the vaginal microbiome in pregnant women.

Measurement of cervical length is used as a screening test because it is inexpensive, has a short learning curve, and is well tolerated by patients. In addition, placement and removal of the pessary is an easy, accessible, and noninvasive procedure. The results on the concentration of omega 3 and preterm birth are still conflicting.

The aim of this study is to compare the effectiveness of the cervical pessary and the natural progesterone in reduction of preterm birth rates in pregnant women with a uterine cervix measuring 25 mm or less in length as evaluated by transvaginal ultrasonography, assess whether there is a relationship between maternal plasma concentration of omega 3 and preterm birth, and compare the microbiome in these women.

Methods: A prospective randomized controlled trial including pregnant women at the time of morphological ultrasound between 20 and 23 weeks and 6 days of pregnancy. Pregnant women in this gestational age with cervical length of 25 mm or less will be randomized between the conduct and the inclusion of progesterone vaginal pessary. In patients of both groups vaginal discharge sample will be collected at the time of randomization. In all pregnant women who accept participate in the study (short cervix or not) will be collected blood sample for measurement of omega 3.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• gestational age between 20 weeks and 23 weeks and 6 days

• singleton pregnancies

Exclusion Criteria:

• no confirmation of the gestational age

• ruptured membranes

• painful regular uterine contractions

• major fetal abnormalities

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Labor

Intervention

Drug:
• natural progesterone

Device:
• cervical pessary

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina da USP	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preterm birth rate before 34 complete weeks of gestation		before 34 weeks of gestation