NCT05944094: PLUVA

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

Completed Last updated 13 July 2023

What this trial tests

trial testing Clorhexidine in Preterm Birth in 1,117 participants. Completed in 16 June 2023.

Timeline

1 June 2021

Primary endpoint
20 December 2022

16 June 2023

Quick facts

Lead sponsor	Instituto de Investigacion Sanitaria La Fe
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,117
Start date	1 June 2021
Primary completion	20 December 2022
Estimated completion	16 June 2023
Sites	1 location across Spain

Drugs / interventions tested

• Clorhexidine

Conditions studied

• Preterm Birth — all drugs for Preterm Birth →

Sponsor

Instituto de Investigacion Sanitaria La Fe — full company profile →

Who can join

Adults 18 to 40, female only, with Preterm Birth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Primary prevention with vaginal chlorhexidine before 16 weeks reduces the incidence of preterm birth: results of the Preterm Labor Prevention Using Vaginal Antiseptics study.
   Morales-Roselló J, Loscalzo G, Martínez-Varea A, Álamo BN, et al · · 2023 · PMID 38107249 · DOI 10.1016/j.xagr.2023.100277