Vaginal Cleansing With Chlorhexidine for Premature Rupture of Membranes

Overseen By Albany Research Coordinator

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Albany Medical College

Must not be taking: Antibiotics, Steroids

Disqualifiers: Preterm labor, Sepsis, Preeclampsia, IUGR, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether vaginal cleansing with chlorhexidine, an antiseptic, can benefit women with PPROM, a condition where the water breaks too early in pregnancy. Researchers aim to determine if this method can prolong pregnancy and improve health outcomes for both mother and baby. Participants will either receive the chlorhexidine treatment or not, enabling researchers to compare results. Women diagnosed with PPROM between 20 and 33 weeks of pregnancy, without certain complications, may qualify for this trial. As an unphased trial, it offers participants the chance to contribute to important research that could enhance care for future patients with PPROM.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken antibiotics or steroids within 7 days before joining the trial.

What prior data suggests that vaginal cleansing with chlorhexidine gluconate is safe for pregnant women with PPROM?

Research has shown that using chlorhexidine gluconate for vaginal cleansing is generally safe for pregnant women. Studies have found no harmful effects on pregnant women or their newborns from this treatment. In fact, chlorhexidine for vaginal cleansing can lower the risk of infections like endometritis, an inflammation of the uterus lining that can occur after childbirth, especially if the water breaks early. These findings suggest that the treatment is well-tolerated and safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using vaginal cleansing with chlorhexidine gluconate for premature rupture of membranes (PPROM) because it offers a new approach to reducing infection risks. Most standard treatments for PPROM focus on antibiotics to prevent infections, but this method uses a topical antiseptic solution, which may directly target harmful bacteria in the vaginal area. The unique mechanism of chlorhexidine gluconate could potentially reduce infection rates more effectively and quickly, providing a safer environment for both the mother and baby. By exploring this novel technique, researchers hope to improve outcomes and reduce complications associated with early membrane rupture.

What evidence suggests that vaginal cleansing with chlorhexidine gluconate is effective for PPROM?

This trial will compare vaginal cleansing with chlorhexidine gluconate to no vaginal cleansing for patients diagnosed with premature rupture of membranes (PPROM). Research has shown that using chlorhexidine gluconate for vaginal cleansing can reduce the risk of infections like endometritis after childbirth, especially when the water has broken. This method may also lower the risk of very early preterm birth if used before 16 weeks of pregnancy. However, a review of many studies did not find clear improvements in overall outcomes for mothers and babies during labor. Chlorhexidine is generally considered safe, with studies showing no harmful effects for pregnant women and their newborns. While evidence for preventing infections is promising, results on other benefits remain mixed. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for pregnant women diagnosed with PPROM between 20-33 weeks of gestation, without active labor or conditions like sepsis, chorioamnionitis, preeclampsia, IUGR. It excludes those who've received antibiotics or steroids within the past week, have multiple pregnancies, placenta previa, or visible fetal parts/cervical dilation at initial exam.

Inclusion Criteria

I am pregnant, diagnosed with PPROM between 20-33 weeks.

Exclusion Criteria

Placenta previa

Preeclampsia

Intrauterine growth restriction (IUGR)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo vaginal cleansing with chlorhexidine gluconate within 24 hours of PPROM diagnosis

1 day

1 visit (in-person)

Expectant Management

Participants are managed expectantly until delivery, with standard care for PPROM

Up to delivery

Follow-up

Participants are monitored for maternal and neonatal outcomes after delivery

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Vaginal cleansing with chlorhexidine gluconate solution

Trial Overview The study tests if vaginal cleansing with chlorhexidine gluconate can prolong pregnancy in women with PPROM. It's a randomized controlled trial that also looks at maternal and neonatal health outcomes and measures inflammation markers from various biological samples.

How Is the Trial Designed?

Group I: Vaginal cleansing Experimental Treatment 1 Intervention

This group includes patients diagnosed with PPROM that are randomized to undergo vaginal cleansing with chlorhexidine gluconate within 24 hours of PPROM diagnosis.

Group II: No vaginal cleansing Active Control 1 Intervention

This group includes patients diagnosed with PPROM that are randomized to not undergo vaginal cleansing.

Who Is Running the Clinical Trial?

Albany Medical College

Lead Sponsor

Trials

96

Recruited

12,700+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04516226

Vaginal Cleansing With Chlorhexidine Gluconate in ... Randomized controlled trial studying the use of vaginal cleansing with chlorhexidine gluconate for pregnant women with PPROM (preterm pre labor rupture of ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S258993332200012X

Preoperative vaginal cleansing with chlorhexidine vs ... Vaginal cleansing with chlorhexidine reduced the risk for endometritis after cesarean delivery in patients with rupture of membranes when compared with placebo ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10724831/

Primary prevention with vaginal chlorhexidine before 16 ... Universal treatment with vaginal chlorhexidine before 16 weeks reduces the incidence of preterm birth, especially before 34 weeks.

4. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-018-1754-9

What is the result of vaginal cleansing with chlorhexidine ... Meta-analysis did not demonstrate improved maternal or neonatal outcomes with intrapartum vaginal chlorhexidine cleansing.

5. withpower.com withpower.com/trial/phase-rupture-7-2020-2df38

Vaginal Cleansing With Chlorhexidine for Premature ... Research shows that vaginal cleansing with chlorhexidine is generally safe, with no adverse reactions reported in studies involving pregnant women and newborns.

6. ajogmfm.org ajogmfm.org/article/S2589-9333(22)00012-X/abstract

Preoperative vaginal cleansing with chlorhexidine vs ... Results. Vaginal cleansing with chlorhexidine reduced the risk for endometritis after cesarean delivery in patients with rupture of membranes ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12190260/

Vaginal Cleansing and Post-Cesarean Infectious Morbidity ... It is postulated that vaginal cleansing reduces the bacterial load in the vagina and reduces the incidence of postoperative infectious morbidity ...