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

NCT05944094 | Completed DMC FDA Device

• 1 other identifier: PLUVA
• Study Type: observational
• Target: 1,117
• Locations: 1 country
• Sites: 1

Brief 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

Preterm Birth

Keywords

Preterm birth, chlorhexidine, primary prevention

Outcome Measures

Primary Outcomes (1)

• Preterm birth

  Vaginal delivery before 34 weeks

  9 months

Secondary Outcomes (3)

• Cervical shortening

  9 months

• Threatened preterm labor

  9 months

• Premature rupture of membranes

  9 months

Study Arms (1)

Group 1: exposed patients

Group 1: pregnant women who received intravaginal chlorhexidine before 16 weeks of gestation Group 2: pregnant women who did not received intravaginal chlorhexidine e before 16 weeks of gestation

Device: Clorhexidine

Interventions

Clorhexidine DEVICE

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.

Also known as: Code GMDN (Global Medical Device Nomenclature): 47673 - Vaginal mucosa suppository Code NBOG (Notified Body Operations Group): MD0303- CumLaude CLX ®

Group 1: exposed patients

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The population was defined by all pregnant patients previously dated by crown-rump length, who attended the initial control or first trimester screening without evident risk of preterm birth at the time of consultation at the Hospital Universitari i Politécnic La Fe during the year 2021.

You may not qualify if:

• Patients with a history of previous preterm birth.
• Patients with vaginal bleeding during the first trimester.
• Patients with abnormalities detected in the first trimester ultrasound scan.
• Twin pregnancies
• Patients with a known allergy to the topical use of Chlorhexidine in any of its forms of presentation.

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead
• Hospital Universitario La Fe: collaborator

Study Sites (1)

Hospital Uiversitario y Politécnico La Fe

Valencia, 46026, Spain

Location

Related Publications (5)

• Brown RG, Marchesi JR, Lee YS, Smith A, Lehne B, Kindinger LM, Terzidou V, Holmes E, Nicholson JK, Bennett PR, MacIntyre DA. Vaginal dysbiosis increases risk of preterm fetal membrane rupture, neonatal sepsis and is exacerbated by erythromycin. BMC Med. 2018 Jan 24;16(1):9. doi: 10.1186/s12916-017-0999-x.

  PMID: 29361936 BACKGROUND

• MacIntyre DA, Chandiramani M, Lee YS, Kindinger L, Smith A, Angelopoulos N, Lehne B, Arulkumaran S, Brown R, Teoh TG, Holmes E, Nicoholson JK, Marchesi JR, Bennett PR. The vaginal microbiome during pregnancy and the postpartum period in a European population. Sci Rep. 2015 Mar 11;5:8988. doi: 10.1038/srep08988.

  PMID: 25758319 RESULT

• Romero R, Hassan SS, Gajer P, Tarca AL, Fadrosh DW, Nikita L, Galuppi M, Lamont RF, Chaemsaithong P, Miranda J, Chaiworapongsa T, Ravel J. The composition and stability of the vaginal microbiota of normal pregnant women is different from that of non-pregnant women. Microbiome. 2014 Feb 3;2(1):4. doi: 10.1186/2049-2618-2-4.

  PMID: 24484853 RESULT

• Spear GT, French AL, Gilbert D, Zariffard MR, Mirmonsef P, Sullivan TH, Spear WW, Landay A, Micci S, Lee BH, Hamaker BR. Human alpha-amylase present in lower-genital-tract mucosal fluid processes glycogen to support vaginal colonization by Lactobacillus. J Infect Dis. 2014 Oct 1;210(7):1019-28. doi: 10.1093/infdis/jiu231. Epub 2014 Apr 15.

  PMID: 24737800 RESULT

• Leitich H, Kiss H. Asymptomatic bacterial vaginosis and intermediate flora as risk factors for adverse pregnancy outcome. Best Pract Res Clin Obstet Gynaecol. 2007 Jun;21(3):375-90. doi: 10.1016/j.bpobgyn.2006.12.005. Epub 2007 Jan 22.

  PMID: 17241817 RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• José Morales-Roselló, Prof.Dr

  Instituto de Investigación Sanitaria La Fe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 13, 2023
• Study Start: June 1, 2021
• Primary Completion: December 20, 2022
• Study Completion: June 16, 2023
• Last Updated: July 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)