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Tearing of Membranes Before Birth - a Comparison Between Two Ways of Induction of Labor Pitocin Opposite Prostaglandin

25. mai 2016 oppdatert av: Tel-Aviv Sourasky Medical Center
Premature rupture of membranes (PROM) is a common occurrence that occurs in the incidence of 8-10% of births. Since the duration until delivery is important in avoiding the risk of complications, several studies have been performed in order to understand what is the preferred way to manage this condition of PROM in women that are not in active labor. In the largest random study that has been performed 20 years ago, there was found an advantage for labor induction with oxytocin over labor induction with Prostaglandin or waiting. However, the most important component - the BISHOP score, that affects the decision of the labor induction way, was not reported and was not taken into consideration.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Premature rupture of membranes (PROM) is a common occurrence that occurs in the incidence of 8-10% of births. Since the duration until delivery is important in avoiding the risk of complications, several studies have been performed in order to understand what is the preferred way to manage this condition of PROM in women that are not in active labor. In the largest random study that has been performed 20 years ago, there was found an advantage for labor induction with oxytocin over labor induction with Prostaglandin or waiting. However, the most important component - the BISHOP score, that affects the decision of the labor induction way, was not reported and was not taken into consideration.

Therefore, the aim of the study is to compare randomly the perinatal outcomes in women with PROM and low BISHOP between women who undergo labor induction with Oxytocin and women who undergo labor induction with Prostaglandin E2.

Studietype

Intervensjonell

Registrering (Forventet)

1200

Fase

  • Fase 3

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 42 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  1. rupture of membranes in BISHOP score lower than 7.
  2. Pregnancy week 34+0 and onward.
  3. Singleton pregnancy.
  4. Verifying fetal monitoring.
  5. Normal maternal temperature (lower than 37.8)
  6. Without vaginal bleeding or suspected placental separation
  7. Contractions in frequency of less than 3 in 10 minutes
  8. Signed consent form.

Exclusion Criteria:

  1. Multiple pregnancy.
  2. Maternal age below 18 or over 42.
  3. Active labor
  4. Contractions in frequency of more than 3 in 10 minutes or cervical dilation ≥2 cm.
  5. Lack of consent to participate in the study

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intravenous oxytocin

Women that arrive to women's ER and diagnosed with rupture of membranes in week 34+0 and onward, are not in active labor and with Bishop score lower than 7.

Those who agreed to participate in the study after signing an informed consent form will undergo the following steps:

  1. Verification rupture of membranes and gestational age.
  2. Choosing the treatment group Intravenous oxytocin from red envelope, randomly.
  3. Collecting basic and obstetric data, laboratory results and physical examination, monitoring and sonar.
  4. Induction according to departmental protocol of each delivery way.
  5. Data collecting after the delivery.
Legemiddel: Intravenous oxytocin

Intravenous oxytocin chosen randomly. we will collect basic and obstetric data, laboratory results and physical examination, monitoring and sonar.

Induction according to departmental protocol of each delivery way. Data collecting after the delivery.
Eksperimentell: vaginal prostaglandin

Women that arrive to women's ER and diagnosed with rupture of membranes in week 34+0 and onward, are not in active labor and with Bishop score lower than 7.

Those who agreed to participate in the study after signing an informed consent form will undergo the following steps:

  1. Verification rupture of membranes and gestational age.
  2. Choosing the treatment group vaginal prostaglandin from red envelope, randomly.
  3. Collecting basic and obstetric data, laboratory results and physical examination, monitoring and sonar.
  4. Induction according to departmental protocol of each delivery way.
  5. Data collecting after the delivery.
Legemiddel: vaginal prostaglandin

Vaginal prostaglandin chosen randomly. we will collect basic and obstetric data, laboratory results and physical examination, monitoring and sonar.

Induction according to departmental protocol of each delivery way. Data collecting after the delivery.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
The duration from the beginning of labor induction until delivery
Tidsramme: 5 days
5 days

Sekundære resultatmål

Resultatmål
Tidsramme
Duration of labor induction from rupture of membranes until delivery.
Tidsramme: 5 days
5 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Tel-Aviv Sourasky Medical Center

Etterforskere

  • Hovedetterforsker: Sharon Maslovitz, MD, Tel Aviv Medical Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2016

Primær fullføring (Forventet)

1. mai 2019

Studiet fullført (Forventet)

1. mai 2019

Datoer for studieregistrering

Først innsendt

22. mars 2016

Først innsendt som oppfylte QC-kriteriene

25. mars 2016

Først lagt ut (Anslag)

28. mars 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

26. mai 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. mai 2016

Sist bekreftet

1. mai 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 0073-15-TLV

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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