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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | 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 | 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 |
| |
| Azithromycin plus Clindamycin group | the second test group in which the pregnant women administerated Azithromycin and clindamycin (Dalacin®) vaginal gel 5 times per month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | The assessment of efficacy of azithromycin in preventing premature labour.The duration between administrating azithromycin as monotherapy and polytherapy and labour is calculated |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Female above 18 years old
Randomized Controlled prospective study
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| Name | Affiliation | Role |
|---|---|---|
| Raghda R.S Hussein | Beni-Suef University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni-Suef University teaching Hospital | Banī Suwayf | Beni Suweif Governorate | 62511 | Egypt |
Pregnant women with risk for pre mature labour will adiminster azithromycin as monotherapy or polytherapy with clindamycin vaginal cream ,The efficacy of Azithromycin in preventing premature mature labour will be assessed
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| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Organic Chemicals |