Effect of Azithromycin in Preventing Premature Labour

NCT05465304 | Completed FDA Drug

• 1 other identifier: REC-H-PhBSU-21022
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnant With Complication

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

Drug: Azithromycin

Azithromycin plus Clindamycin group

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

Drug: Azithromycin

Interventions

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

Azithromycin group; Azithromycin plus Clindamycin group

Eligibility Criteria

• Age: 18 Years - 32 Years
• Gender Eligibility Details: Female above 18 years old
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Randomized Controlled prospective study

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef University teaching Hospital

Banī Suwayf, Beni Suweif Governorate, 62511, Egypt

Location

MeSH Terms

Conditions

Pregnancy Complications

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Raghda R.S Hussein

  Beni-Suef University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Pharmacy

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 19, 2022
• Study Start: October 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 30, 2022
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)