Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

25 mei 2016 bijgewerkt door: 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.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Verwacht)

1200

Fase

  • Fase 3

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 42 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: 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.
Experimenteel: 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.
Geneesmiddel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
The duration from the beginning of labor induction until delivery
Tijdsspanne: 5 days
5 days

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Duration of labor induction from rupture of membranes until delivery.
Tijdsspanne: 5 days
5 days

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Tel-Aviv Sourasky Medical Center

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2016

Primaire voltooiing (Verwacht)

1 mei 2019

Studie voltooiing (Verwacht)

1 mei 2019

Studieregistratiedata

Eerst ingediend

22 maart 2016

Eerst ingediend dat voldeed aan de QC-criteria

25 maart 2016

Eerst geplaatst (Schatting)

28 maart 2016

Updates van studierecords

Laatste update geplaatst (Schatting)

26 mei 2016

Laatste update ingediend die voldeed aan QC-criteria

25 mei 2016

Laatst geverifieerd

1 mei 2016

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 0073-15-TLV

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren