Using antibiotics to prolong pregnancy after premature rupture of membranes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of outpatient oral antibiotics, specifically amoxicillin and azithromycin, in extending the duration of pregnancy after a premature rupture of membranes (PPROM) in women between 18 and 22 weeks of gestation. Participants diagnosed with PPROM will undergo a 24-hour monitoring period before being randomly assigned to either receive antibiotics or not. The primary outcome measured will be the number of days the pregnancy continues after the rupture. This study aims to provide insights into the management of PPROM and its implications for preterm birth.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Singleton gestation
2. Gestational age of greater than 18 0/7 but less than or equal to 22 6/7
3. Diagnosis of prelabor premature rupture of membranes as determined by clinical examination noting either/or 1) visualization of amniotic fluid passing from the cervical canal and pooling in the vagina via sterile speculum examination, 2) a basic pH (i.e., positive nitrazine) test of vaginal fluid, 3) arborization (ferning) of dried vaginal fluid identified via microscopic examination, or 4) an amniotic fluid index (AFI) of less than 4cm
4. Greater than or equal to 18 years of age
5. Those with no known drug allergies or significant adverse reactions to azithromycin or amoxicillin
6. Afebrile at the time of presentation and throughout 24-hour observation period
7. Patient must be able to provide informed consent

Exclusion Criteria:

1. Fetal anomalies in current pregnancy
2. Diabetes mellitus, including both pre-gestational and gestational
3. Abnormal placentation
4. Poor dating with dating ultrasound performed later than or equal to 20 0/7 weeks
5. Current subchorionic hemorrhage or current vaginal bleeding on presentation
6. Hypertensive disease, including pre-gestational chronic hypertension, gestational hypertension and pre-eclampsia/eclampsia
7. History of amniocentesis during this pregnancy
8. History of cervical incompetence, history of cerclage in previous pregnancy or current cerclage in place
9. Current documented urinary tract infection or bacteriuria
10. Current documented genital tract infection (Chlamydia, gonorrhea, or trichomonas)
11. Immunocompromised (i.e., HIV positive, daily steroid use, or a history of autoimmune disease for which the patient is currently undergoing treatment with immunotherapy medication)

Where it's running

• Woman's Hospital
  Baton Rouge, Louisiana, United States Recruiting

Study contacts

• Principal investigator: Robert C Moore, MD — Woman's Hospital, Louisiana
• Study coordinator: Felicia LeMoine, MD
• Email: fvenab@lsuhsc.edu
• Phone: 2252768164

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Predicting Adverse Pregnancy Outcomes in Uganda through Partnerships and Innovation

  This study tests whether everyday health data, ultrasound, and blood samples from first-time pregnant women in Uganda can help predict problems like preeclampsia, fetal growth restriction, and preterm birth.

  Recruiting at 2 sites Makerere University · Kampala and 1 other locations · NCT07844876

• Cervical stiffness test to help predict preterm birth in at-risk pregnant women

  A simple cervical stiffness test using the Pregnolia device is being studied to see if it can better identify women with threatened preterm labor who are likely to give birth soon.

  Recruiting Pregnolia AG · Prague · NCT07840235

• Prenatal education to reduce environmental exposures during pregnancy

  Aimed at pregnant people, this program tests whether a classroom-style education can help reduce exposure to harmful pollutants from seafood and nearby pollution sources.

  Recruiting at 2 sites The University of Texas Medical Branch, Galveston · Galveston, Texas and 1 other locations · NCT07758114

• Breast milk and sugar solutions to ease heel-prick pain in premature babies

  This study tests whether oral breastfeeding or sugary solutions help relieve pain in premature newborns during a heel-prick blood draw.

  Recruiting Mersin University · Mersin · NCT07716813

• Gentle Touch and Sensory Changes to Ease Heel Pricks in Preterm Babies

  This study tests whether gentle human touch or a quiet, reduced-stimulation environment can reduce pain and improve comfort during heel blood collection for premature infants.

  Recruiting Baskent University · Ankara · NCT07715682

• How doctors and nurses decide about bed rest in pregnancy

  This study tests a plan to stop routinely restricting activity or bed rest during pregnancy to see if providers accept it, find it appropriate, and change how often they recommend it for women at risk of preterm birth.

  Recruiting at 2 sites University of Pennsylvania · Philadelphia, Pennsylvania and 1 other locations · NCT07698483

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.