Effect of Azithromycin in Preventing Premature Labour

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Effect of Azithromycin on Pregnancy Prolongation in Women at Risk for Premature Labour

Conditions
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Pregnant With Complication

Intervention / Treatment
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* Drug: Azithromycin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 32 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>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<br>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 | Drug: Azithromycin<br>* The assessment of efficacy of azithromycin in preventing premature labour.The duration between administrating azithromycin as monotherapy and polytherapy and labour is calculated<br>|
| Azithromycin plus Clindamycin group<br>the second test group in which the pregnant women administerated Azithromycin and clindamycin (Dalacin®) vaginal gel 5 times per month. | Drug: Azithromycin<br>* The assessment of efficacy of azithromycin in preventing premature labour.The duration between administrating azithromycin as monotherapy and polytherapy and labour is calculated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Azithromycin in preventing premature labour | Main outcome was the number of days between diagnosis and composite event, defined as delivery or rupture of membranes or 2nd intervention aimed at prolonging pregnancy (such as cerclage or tocolysis) or censure (maternal death or transfer). The three groups were compared regarding this number of days | 6 monthes |