MedTrace Logo

Preterm Labor Prevention Using Vaginal Antiseptics Prior to 16 Weeks of Gestation

NCT05944094 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1117

Last updated 2023-07-13

No results posted yet for this study

Summary

The aim of this prospective observational study was to evaluate the efficacy of a universal strategy of primary prevention of preterm birth using intravaginal chlorhexidine (CLX) applied before 16 weeks.

The main question is whether universal treatment with vaginal CLX before 16 weeks would reduce the incidence of preterm birth, especially before 34 weeks.

Participants were recruited at the routine first trimester consultation. All patients underwent an initial ultrasound examination between 6+0 and 15+6 weeks gestation, including assessment of embryo/fetus vitality.

Antiseptic treatment aimed at reducing possible bacterial overgrowth consisted of 10 days (1 box) of CLX vaginal ovules (CLX digluconate 0.2%) always starting between 9+0 and 16+0 weeks.

As this product is widely marketed and frequently indicated in gynaecology, we did not deprive the non-treated group of treatment because we wanted to assess whether it could have an effect on reducing preterm delivery.

The pregnant women were then followed up until the end of pregnancy and compared with a cohort of patients who had not received any treatment.

All data related to delivery were collected, as well as any events related to preterm delivery, such as onset of contractions, cervical shortening and premature rupture of membranes, regardless of final gestational age at delivery.

Conditions

Interventions

DEVICE

Clorhexidine

Antiseptic treatment aimed at reducing potential bacterial overgrowth consisted of 10 days (1 box) of vaginal ovules of CLX (CumLaude CLX ® , CLX digluconate 0.2%) always starting between 10+0 and 16+0 weeks.

Sponsors & Collaborators

  • Hospital Universitario La Fe

    collaborator OTHER

  • Instituto de Investigacion Sanitaria La Fe

    lead OTHER

Principal Investigators

  • José Morales-Roselló, Prof.Dr · Instituto de Investigación Sanitaria La Fe

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-12-20
Completion
2023-06-16
FDA Device
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05944094 on ClinicalTrials.gov