Comparison of Two Antibiotic Prophylactic Protocols in Preterm Premature Rupture of the Membranes
NCT ID: NCT02819570
Last Updated: 2016-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
400 participants
INTERVENTIONAL
2015-11-30
2017-12-31
Brief Summary
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Detailed Description
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An increase in EOS due to gram negative Enterobacteriaceae have been reported lately with a relative decrease in GBS related EOS . These data may have an impact on the antibiotic regimen used for PPROM. The Local pathogens distribution in cases of EOS and their antibiotic sensitivity profiles in Northern Israel have been explored in a multicenter study There were 27 neonates diagnosed with EOS with positive blood cultures. Aerobic Enterobacteriaceae accounted for 14 cases (52%) and group B streptococcus for 7 cases (26%). Of the Escherichia coli and Klebsiella sp.,only 38% were sensitive to ampicillin. As a result the most effective antibiotic protocol to cover those pathogens is required. The purpose of the current study is to compare a new antibiotic protocol with the current prophylactic treatment in use and to evaluate pregnancy and neonatal outcome.
The diagnosis of preterm premature rupture of membranes (PPROM) is clinical, and is based on visualization of amniotic fluid in the vagina of a woman who presents with a history of leaking fluid. Laboratory tests as "Amniosure" can be used to confirm the clinical diagnosis when it is uncertain.
Women who meet the study criteria and have signed inform consent will be randomly divided in two groups to receive prophylactic antibiotic treatment as follow:
1. I.V ampicillin 2 gram x4/d for 2 days followed by P.O moxypen 500 mgx3/d for additional 5 days+ P.O roxithromycin 150 mg\*2/d for 7 days
2. I.V cefuroxime 750 mg\*3/d for 2days followed by P.O cefuroxime 500 mgx2/d + P.O roxithromycin 150 mg\*2/d for 7 days
A course of corticosteroids will be given to all women participating in the study
Expectant management:
1. Vital signs \*3/day
2. Uterine tenderness evaluation
3. Complete Blood Count + C-reactive protein every second day
4. Urine culture and GBS recto-vaginal swab
5. Fetal heart monitoring\*6 /d
6. Sonography evaluation every 2-3 days
7. Vaginal swab once a week
8. Fetal movements follow up
Labor induction will be conducted at 34 weeks of gestation If chorioamnionitis is suspected amniocentesis should be considered or expeditious delivery
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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cefuroxime
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
I.V cefuroxime 750 mg*3/d for 2 days
P.O cefuroxime 500 mgx2/d for 5 days
P.O roxithromycin 150 mg*2/d for 7 days
ampicillin
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
I.V ampicillin 2 gram x4/d for 2 days
P.O roxithromycin 150 mg*2/d for 7 days
P.O moxypen 500 mgx3/d for 5 days
Interventions
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I.V cefuroxime 750 mg*3/d for 2 days
I.V ampicillin 2 gram x4/d for 2 days
P.O cefuroxime 500 mgx2/d for 5 days
P.O roxithromycin 150 mg*2/d for 7 days
P.O moxypen 500 mgx3/d for 5 days
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Suspected fetal distress or chorioamnionitis
* Active labor
* Drug allergy to one of the study regiments
* Immune deficiency
* Multiple pregnancy
18 Years
45 Years
FEMALE
No
Sponsors
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Western Galilee Hospital-Nahariya
OTHER_GOV
Responsible Party
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Dr. Maya Wolf
MD
Principal Investigators
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Maya Wolf, MD
Role: PRINCIPAL_INVESTIGATOR
1Department of Obstetrics & Gynecology, Galilee Medical Center, 2Faculty of Medicine in the Galilee, Bar Ilan University, Nahariya, Israel
Locations
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Galil Medical Center
Nahariya, Israel, Israel
Countries
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Central Contacts
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Facility Contacts
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Maya Wolf, MD
Role: primary
References
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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.
Newton ER. Chorioamnionitis and intraamniotic infection. Clin Obstet Gynecol. 1993 Dec;36(4):795-808. doi: 10.1097/00003081-199312000-00004.
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.
Practice bulletins No. 139: premature rupture of membranes. Obstet Gynecol. 2013 Oct;122(4):918-930. doi: 10.1097/01.AOG.0000435415.21944.8f.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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0149-15-NHR
Identifier Type: -
Identifier Source: org_study_id