Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

25. maj 2016 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

1200

Fase

  • Fase 3

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 42 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.
Eksperimentel: 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.
Medicin: 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.

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tel-Aviv Sourasky Medical Center

Efterforskere

  • Ledende efterforsker: Sharon Maslovitz, MD, Tel Aviv Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2016

Primær færdiggørelse (Forventet)

1. maj 2019

Studieafslutning (Forventet)

1. maj 2019

Datoer for studieregistrering

Først indsendt

22. marts 2016

Først indsendt, der opfyldte QC-kriterier

25. marts 2016

Først opslået (Skøn)

28. marts 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. maj 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. maj 2016

Sidst verificeret

1. maj 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 0073-15-TLV

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner