Treatment of Classic Mid-trimester PPROM by Means of Continuous Amnioinfusion

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Brief Title

Treatment of Classic Mid-trimester PPROM by Means of Continuous Amnioinfusion

Official Title

Treatment of Classic Mid-trimester Preterm Premature Rupture of Membranes (PPROM) With Oligo/Anhydramnion Between 22/0-26/0 Week of Gestation by Means of Continuous Amnioinfusion: a Multicenter Prospectiv Randomized Trial

Brief Summary

      Objective: Mid-trimester preterm premature rupture of membranes (PPROM), defined as rupture
      of fetal mem-branes prior to 28 weeks' gestation (WG), complicates approximately 0.4-0.7% of
      all pregnancies and associated with very high neonatal mortality and morbidity. Antibiotics
      have limited success to prevent bacteremia, chorioamnionitis and fetal inflammation because
      of reduced placental transport. The repetitive amnioinfusion doesn't work because of
      immediately fluid lost after the intervention). The continuous amnioinfusion with Amnion
      Flush Solution through the perinatal port system in patients with classic PPROM prolonged the
      PPROM-to-delivery interval to 49 days in average by flush out of bacteria and inflammatory
      components from the amniotic cavity.

      Aim: This multicenter trial tests the effect of continuous amnioinfusion on the neonatal
      survival without major morbidities, like severe bronchopulmonary dysplasia, intraventricular
      hemorrhage, cystic periventricular leukomalacia and necrotizing enterocolitis.

      Design: randomized multicenter controlled trial; two-arm parallel design. Control group: 34
      PPROM patients between 22/0 (20/0) -26/0 WG treating with antibiotics and corticosteroids in
      according to DGGG guide-lines. In interventional group (n=34) the standard PPROM therapy will
      be complemented by "Amnion -Flush" method with the amnioinfusion of artificial amniotic fluid
      (Amnion Flush Solution, Serumwerk AG, Germany, 2400 ml/d).

      Subjects: Patients with classic PPROM between 22/0-26/0 WG. Expected outcome:The
      investigators expect significant reduction of neonatal mortality and morbidity in the
      "Amnion-Flush" group.
    

Detailed Description

      Objective:

      Mid-trimester preterm premature rupture of membranes (PPROM), defined as rupture of fetal
      mem-branes prior to 28 weeks' gestation (WG), complicates approximately 0.4-0.7% of all
      pregnancies and associated with very high neonatal mortality and morbidity. Antibiotics have
      limited success to prevent bacteremia, chorioamnionitis and fetal inflammation because of
      reduced placental transport. The repetitive amnioinfusion doesn't work because of immediately
      fluid lost after the intervention). The continuous amnioinfusion with Amnion Flush Solution
      through the perinatal port system in patients with classic PPROM prolonged the
      PPROM-to-delivery interval to 49 days in average by flush out of bacteria and inflammatory
      components from the amniotic cavity.

      Aim: This multicenter trial tests the effect of continuous amnioinfusion on the neonatal
      survival without major morbidities, like severe bronchopulmonary dysplasia, intraventricular
      hemorrhage, cystic periventricular leukomalacia and necrotizing enterocolitis.

      Design: randomized multicenter controlled trial; two-arm parallel design.

      Control group:

      34 PPROM patients between 22/0 (20/0) -26/0 WG treating with antibiotics and corticosteroids
      in according to DGGG guide-lines (7 days Amoxicillin/Clarithromycin therapy or 7 days
      Amoxicillin and once Azithromycin 1 g and corticosteroids' RDS prophylaxis).

      Experimental group:

      34 PPROM patients between 22/0 (20/0) -26/0 WG, continuous amnioinfusion (100 ml/h) in
      pregnant women with classic PPROM with oligo-/anhydramnion between 22/0- 26/0 weeks'
      gestation and systemic antibiotic therapy (7 days Amoxicil-lin/Clarythromycin or 7 days
      Amoxicillin and once Azithromycin 1 g) and corticosteroids' RDS prophylaxis.

      Duration of intervention: Maximum till 34/0 weeks of gestation, or preterm delivery if
      indicated.

      Follow-up per patient: 12 months post-partum. Subjects: Patients with classic PPROM between
      22/0 (20/0) -26/0 WG. Primary efficacy endpoint: survival without major morbidity (severe
      bron-chopulmonary dysplasia (BPD), and/or grades 3 and 4 intraventricular hemor-rhage (IVH
      3-4), and/or cystic periventricular leukomalacia (cPVL), and/or necrotizing enterocolitis
      (NEC)) since randomization (event time).

      Expected outcome: The envestigators expect significant reduction of neonatal mortality and
      morbidity in the "Amnion-Flush" group.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Number of Participants with bronchopulmonary dysplasia

Secondary Outcome

 Duration of PPROM to delivery interval

Condition

Bronchopulmonary Dysplasia

Intervention

Continuous amnioinfusion with Amnion Flush Solution through the intraamniotic catheter

Study Arms / Comparison Groups

 control
Description:  The patients with classic PPROM between 22/0-26/0 weeks' gestation with oligo/anhydramnion with standard conservative treatment (7 days Amoxicillin/Clarithromycin therapy or 7 days Amoxicillin and once Azithromycin 1 g per os, and corticosteroids like Celestan®, Essex Pharma, Munich, Germany) as RDS prophylaxis will represent the control group (DGGG Guideline AWMF 015-025, February 2019, Version 1.0). The diagnosis of the PPROM must be not early than 20/0 weeks' gestation.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Combination Product

Estimated Enrollment

68

Start Date

January 1, 2021

Completion Date

May 30, 2025

Primary Completion Date

August 31, 2024

Eligibility Criteria

        Inclusion Criteria:

          -  Singleton pregnancy (from 22/0 to 26/0 weeks of gestation)

          -  Evidence of PPROM from clinical and instrumental investigations

          -  Oligo/anhydramnion (< 2 cm deepest amniotic fluid pocket)

        Exclusion Criteria:

          -  fetal death

          -  placental abnormalities

          -  labor

          -  evidence of major structural or chromosomal abnormalities

          -  signs of chorioamnionitis (maternal fever > 38° C and one or more of the following
             criteria: uterine tenderness, malodorous vag-inal discharge, maternal leukocytosis >
             15000 cells/mm3, maternal tachycardia > 100 beats/min, and fetal heart rate > 160
             bpm).
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Michael Tchirikov, MD, Ph.D., -345-57-3250, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT04696003

Organization ID

2020-185


Responsible Party

Principal Investigator

Study Sponsor

Martin-Luther-Universität Halle-Wittenberg


Study Sponsor

Michael Tchirikov, MD, Ph.D., Study Director, University Clinic of Obstetrics and Prenatal Medicine


Verification Date

January 2021