Effect of Azithromycin in Preventing Premature Labour

Beni-Suef University

Status: Completed

Conditions: Pregnant With Complication

Treatments: Drug: Azithromycin

Study type: Observational

Funder types: Other

Identifiers

NCT05465304

REC-H-PhBSU-21022

Details and patient eligibility

About

This is a prospective observational case controlled study. The control group will include pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy.

The test group will involve pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy plus azithromycin

Full description

A prospective randomized clinical study was conducted in the outpatient clinic of the gynecology department of Beni Suef University Hospital, Beni-Suef, Egypt, between October 01, 2021, and April 30, 2022. The study included 211 pregnant women aged between 20 to 41 years. These patients were randomized into three groups.

The first group which was the control group, included pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments (progesterone) for prolongation of pregnancy. While the second group which was the first test group, involved pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy plus azithromycin for 5 days every month.

. The third group was the second test group in which the pregnant women administerated Azithromycin and clindamycin (Dalacin®) vaginal gel 5 times per month.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 32 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women with <34 weeks of gestation,
• Hospitalization for risk of preterm labour,
• Threat of preterm labour, or preterm labour itself.
• Threat of preterm labour and preterm labour will have to be diagnosis cited in the medical record by the physician.
• Women at risk of preterm labour must have one of the following conditions cited in their record: sludge, short cervix, cerclage, or bulging membranes

Exclusion criteria

• Patients were excluded from the current study in case of the use of antibiotics within 14 days before the admission (except for pericerclage prophylaxis, or streptococcus B prophylaxis), PPROM or fetal extraction required <37 weeks.

Trial design

200 participants in 3 patient groups

Control group

Description:

control group, included pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments (progesterone) for prolongation of pregnancy.

Azithromycin group

Description:

the first test group, involved pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy plus azithromycin for 5 days every month

Treatment:

Drug: Azithromycin

Azithromycin plus Clindamycin group

Description:

the second test group in which the pregnant women administerated Azithromycin and clindamycin (Dalacin®) vaginal gel 5 times per month.

Treatment:

Drug: Azithromycin