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The Use of D5LR Versus LR for Induction of Labor and Time to Delivery in Multiparous and Primiparous Patient's With Favorable and Unfavorable Bishop's Scores

20. december 2019 opdateret af: Katelyn Hartung, Ascension Genesys Hospital

A Randomized Controlled Trial Comparing D5LR to LR for Induction of Labor and Time to Delivery in Multiparous and Primiparous Patient's With Favorable and Unfavorable Bishop's Scores

Currently, the optimum IV fluid for induction of labor is unknown. The goal of this study is to determine the optimum fluid for induction of labor, D5LR versus LR. The investigators hypothesize that patients assigned to the D5LR group will have a shorter induction of labor when compared to patient's in the LR group.

Studieoversigt

Detaljeret beskrivelse

Induction of labor is increasingly common in the United States, as the overall rate has increased from 9.5% in 1990 to 22.1% in 2006 with the goal to stimulate contractions prior to the onset of spontaneous labor. Cesarean delivery rates are also at an all-time high in the U.S., with more than 32% of patients being delivered by Cesarean in 2009. One of the most common indications for Cesarean section is a prolonged labor course. Patient's with a prolonged labor course are also at risk for infections, including chorioamnionitis and endometritis, as well as an increased risk of postpartum hemorrhage. There is a lack of information on ways to help shorten labor to potentially minimize these risks.

The uterus is comprised of skeletal muscle, and labor has been likened to prolonged rigorous exercise. While oral hydration has been endorsed by ACOG for low-risk women in spontaneous labor, solid foods should be avoided. In turn, women with a prolonged induction or labor may benefit from glucose supplementation via IV fluids.

The DEXTRONS study, J. Pare et al., looked at supplementation of D5LR versus normal saline in nulliparous patients who presented for a favorable induction of labor. This study showed a significant reduction in active labor time in the D5LR group versus the normal saline group.

Currently, at Genesys Regional Medical Center, lactated ringers is the preferred IV fluid for patients presenting for induction of labor. This study will randomly assign patients to D5LR versus lactated ringers and examine the length of time from induction to delivery to determine if glucose supplementation has an effect on reducing length of induction in both nulliparous and multiparous patients for either a favorable induction of labor or an induction for post-dates. Secondary outcomes will include Apgar scores, need for special care nursery/NICU admissions, and mode of delivery. The study will begin in January 2019 and continue through July 2019. Patients who presented to labor and delivery and consent to be included in the study will be randomized to each group.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

39

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

    • Michigan
      • Grand Blanc, Michigan, Forenede Stater, 48439
        • Ascension Genesys Hospital

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 45 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Pregnant women, age 18 - 45, that were admitted for induction of labor without any co-morbid conditions and their respective newborns with
  • Induction of labor
  • Singleton pregnancies
  • Vertex presentation
  • Pregnancies at 39 0/7 weeks gestation - 41 6/7 weeks gestation
  • All races/ethnicities

Exclusion Criteria:

  • Multifetal gestations
  • Noncephalic presentation
  • Preexisting medical conditions:
  • Maternal cardiac disease
  • Lung diseases
  • Chronic hypertension
  • Pregestational or gestational diabetes
  • gHTN or Pre-Eclampsia
  • medical indication for induction of labor (olighydramnios, IUGR)

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Primiparous Patient, Unfavorable Bishop Score
Patient to receive D5LR or LR at 125 cc/hr
IV fluid
IV fluid
Aktiv komparator: Primiparous Patient, Favorable Bishop Score
Patient to receive D5LR or LR at 125 cc/hr
IV fluid
IV fluid
Aktiv komparator: Multiparous patient, Unfavorable Bishop Score
Patient to receive D5LR or LR at 125 cc/hr
IV fluid
IV fluid
Aktiv komparator: Multiparous patient, Favorable Bishop Score
Patient to receive D5LR or LR at 125 cc/hr
IV fluid
IV fluid

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time of induction
Tidsramme: 492 min +/- 35 min
Time from start of labor induction to delivery of infant
492 min +/- 35 min

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time of Active Labor
Tidsramme: 4 hours +/- 3 hours
time from 6 cm dilation until delivery of infant
4 hours +/- 3 hours
Apgar Scores
Tidsramme: 492 min +/- 35 min
validated measure of infant health
492 min +/- 35 min
Mode of Delivery
Tidsramme: 492 min +/- 35 min
Cesarean section vs SVD vs OVD
492 min +/- 35 min
Neonatal ICU admissions
Tidsramme: 24 hours after delivery
ICU or special care nursery admissions
24 hours after delivery
Need for respiratory support
Tidsramme: 24 hours after delivery
Neonatal need for respiratory support
24 hours after delivery
Transfer to tertiary care center
Tidsramme: 24 hours after delivery
neonatal need for transfer to higher level NICU
24 hours after delivery

Samarbejdspartnere og efterforskere

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Publikationer og nyttige links

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Generelle publikationer

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 (Faktiske)

15. marts 2019

Primær færdiggørelse (Faktiske)

15. november 2019

Studieafslutning (Faktiske)

19. december 2019

Datoer for studieregistrering

Først indsendt

18. januar 2019

Først indsendt, der opfyldte QC-kriterier

28. januar 2019

Først opslået (Faktiske)

30. januar 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. december 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. december 2019

Sidst verificeret

1. december 2019

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • ME 19 004

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