Comparison of Two Antibiotic Prophylactic Protocols in Preterm Premature Rupture of the Membranes

NCT02819570 | Unknown Phase 4

• 1 other identifier: 0149-15-NHR
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to compare a new antibiotic protocol with the current prophylactic treatment in routine use and to evaluate obstetric and neonatal outcome: preterm labor, chorioamnionitis and early onset sepsis

Conditions

Premature Rupture of Membrane

Keywords

early-onset neonatal sepsis; Prophylactic antibiotics; Pregnancy; PPROM; EOS

Outcome Measures

Primary Outcomes (3)

• EARLY NEONATAL SEPSIS - positive blood culture

  Number of Participants with early neonatal sepsis

  within 3 days of delivery

• latency period

  time in days

  from date of randomization until the date of delivery assessed up to 10 weeks

• Chorioamnionitis rate

  rate of positive cultures

  from day of randomization until date of clinical/laboratory chorioamnionitis diagnosis assessed up to 10 weeks

Secondary Outcomes (2)

• Neonatal weight

  at delivery

• Apgar score

  1 minute 5 minute

Other Outcomes (2)

• Number of participants with adverse events as assessed by umbilical cord acid-based analysis<7

  at delivery

• Neonatal intensive care unit (NICU) admission duration

  days since delivery until rerelease from NICU, assessed up to 6 month

Study Arms (2)

cefuroxime

EXPERIMENTAL

I.V cefuroxime 750 mg\*3/d for 2days followed by P.O cefuroxime 500 mgx2/d in addition to P.O roxithromycin 150 mg\*2/d for 7 days

Drug: I.V cefuroxime 750 mg*3/d for 2 days; Drug: P.O cefuroxime 500 mgx2/d for 5 days; Drug: P.O roxithromycin 150 mg*2/d for 7 days

ampicillin

ACTIVE COMPARATOR

I.V ampicillin 2 gram x4/d for 2 days followed by P.O moxypen 500 mgx3/d for 5 days in addition to P.O roxithromycin 150 mg\*2/d for 7 days

Drug: I.V ampicillin 2 gram x4/d for 2 days; Drug: P.O roxithromycin 150 mg*2/d for 7 days; Drug: P.O moxypen 500 mgx3/d for 5 days

Interventions

I.V cefuroxime 750 mg*3/d for 2 days DRUG

cefuroxime

I.V ampicillin 2 gram x4/d for 2 days DRUG

ampicillin

P.O cefuroxime 500 mgx2/d for 5 days DRUG

cefuroxime

P.O roxithromycin 150 mg*2/d for 7 days DRUG

ampicillin; cefuroxime

P.O moxypen 500 mgx3/d for 5 days DRUG

ampicillin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with PPROM between 24+0 and 34+0 weeks of gestation who are suitable for conservative management

You may not qualify if:

• P-PROM\>34 weeks of gestation
• Suspected fetal distress or chorioamnionitis
• Active labor
• Drug allergy to one of the study regiments
• Immune deficiency
• Multiple pregnancy

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Study Sites (1)

Galil Medical Center

Nahariya, Israel, Israel

RECRUITING

Related Publications (15)

• Mercer BM. Preterm premature rupture of the membranes: current approaches to evaluation and management. Obstet Gynecol Clin North Am. 2005 Sep;32(3):411-28. doi: 10.1016/j.ogc.2005.03.003.

  PMID: 16125041 BACKGROUND

• Newton ER. Chorioamnionitis and intraamniotic infection. Clin Obstet Gynecol. 1993 Dec;36(4):795-808. doi: 10.1097/00003081-199312000-00004.

  PMID: 8293582 BACKGROUND

• Sperling RS, Newton E, Gibbs RS. Intraamniotic infection in low-birth-weight infants. J Infect Dis. 1988 Jan;157(1):113-7. doi: 10.1093/infdis/157.1.113.

  PMID: 3335795 BACKGROUND

• Practice bulletins No. 139: premature rupture of membranes. Obstet Gynecol. 2013 Oct;122(4):918-930. doi: 10.1097/01.AOG.0000435415.21944.8f.

  PMID: 24084566 BACKGROUND

• Carlan SJ, O'Brien WF, Parsons MT, Lense JJ. Preterm premature rupture of membranes: a randomized study of home versus hospital management. Obstet Gynecol. 1993 Jan;81(1):61-4.

  PMID: 8416463 BACKGROUND

• Turnbull DA, Wilkinson C, Gerard K, Shanahan M, Ryan P, Griffith EC, Kruzins G, Stamp GE. Clinical, psychosocial, and economic effects of antenatal day care for three medical complications of pregnancy: a randomised controlled trial of 395 women. Lancet. 2004 Apr 3;363(9415):1104-9. doi: 10.1016/S0140-6736(04)15893-5.

  PMID: 15064028 BACKGROUND

• Roberts D, Dalziel S. Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD004454. doi: 10.1002/14651858.CD004454.pub2.

  PMID: 16856047 BACKGROUND

• Harding JE, Pang J, Knight DB, Liggins GC. Do antenatal corticosteroids help in the setting of preterm rupture of membranes? Am J Obstet Gynecol. 2001 Jan;184(2):131-9. doi: 10.1067/mob.2001.108331.

  PMID: 11174492 BACKGROUND

• Kenyon S, Boulvain M, Neilson JP. Antibiotics for preterm rupture of membranes. Cochrane Database Syst Rev. 2013 Dec 2;2013(12):CD001058. doi: 10.1002/14651858.CD001058.pub3.

  PMID: 24297389 BACKGROUND

• Mercer BM, Miodovnik M, Thurnau GR, Goldenberg RL, Das AF, Ramsey RD, Rabello YA, Meis PJ, Moawad AH, Iams JD, Van Dorsten JP, Paul RH, Bottoms SF, Merenstein G, Thom EA, Roberts JM, McNellis D. Antibiotic therapy for reduction of infant morbidity after preterm premature rupture of the membranes. A randomized controlled trial. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. JAMA. 1997 Sep 24;278(12):989-95.

  PMID: 9307346 BACKGROUND

• Workowski KA, Berman S; Centers for Disease Control and Prevention (CDC). Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep. 2010 Dec 17;59(RR-12):1-110.

  PMID: 21160459 BACKGROUND

• Grigsby PL, Novy MJ, Sadowsky DW, Morgan TK, Long M, Acosta E, Duffy LB, Waites KB. Maternal azithromycin therapy for Ureaplasma intraamniotic infection delays preterm delivery and reduces fetal lung injury in a primate model. Am J Obstet Gynecol. 2012 Dec;207(6):475.e1-475.e14. doi: 10.1016/j.ajog.2012.10.871. Epub 2012 Oct 23.

  PMID: 23111115 BACKGROUND

• Wolf MF, Miron D, Peleg D, Rechnitzer H, Portnov I, Salim R, Keness Y, Reich D, Ami MB, Peretz A, Koshnir A, Shachar IB. Reconsidering the Current Preterm Premature Rupture of Membranes Antibiotic Prophylactic Protocol. Am J Perinatol. 2015 Nov;32(13):1247-50. doi: 10.1055/s-0035-1552935. Epub 2015 May 29.

  PMID: 26023907 BACKGROUND

• Sgayer I, Francis YN, Miron D, Shprits E, Sheffer VF, Rechnitzer H, Lowenstein L, Wolf MF. Compared perinatal outcomes of two prophylactic antibiotic regimens for preterm premature rupture of membranes: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 May;5(5):100900. doi: 10.1016/j.ajogmf.2023.100900. Epub 2023 Feb 13.

  PMID: 36791845 DERIVED

• Wolf MF, Sgayer I, Miron D, Krencel A, Sheffer VF, Idriss SS, Sammour RN, Peleg D, Shachar IB, Rechnitzer H, Bornstein J. A novel extended prophylactic antibiotic regimen in preterm pre-labor rupture of membranes: A randomized trial. Int J Infect Dis. 2020 Jul;96:254-259. doi: 10.1016/j.ijid.2020.05.005. Epub 2020 May 11.

  PMID: 32407901 DERIVED

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture; Neonatal Sepsis; Preterm Premature Rupture of the Membranes

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maya Wolf, MD

  1Department of Obstetrics & Gynecology, Galilee Medical Center, 2Faculty of Medicine in the Galilee, Bar Ilan University, Nahariya, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Wolf, MD

CONTACT

972-507887800; homesickid@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 30, 2016
• Study Start: November 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 29, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)