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Comparing Intra-Umbilical Versus Intravenous Oxytocin in Women During the Third Stage of Labor for Reducing Blood Loss

28. april 2026 opdateret af: Dr. Sana Siddique, CMH Multan Institute of Medical Sciences

Comparing the Effect of Intra-Umbilical Versus Intravenous Oxytocin During Third Stage of Labor on Mean Blood Loss

The goal of this clinical trial is to determine whether giving oxytocin through the umbilical cord is more effective than giving it through a vein in reducing blood loss during the third stage of labor. The third stage of labor is the period between the birth of the baby and the delivery of the placenta. Excessive bleeding after delivery, known as postpartum hemorrhage, is a major cause of maternal illness and death worldwide. Oxytocin is commonly used to help the uterus contract and reduce bleeding after childbirth.

The main question this study aims to answer is:

Does intra-umbilical oxytocin reduce the average amount of blood loss during the third stage of labor compared with intravenous oxytocin?

Researchers will conduct a randomized controlled trial involving 60 women with uncomplicated pregnancies who are in spontaneous labor. Participants will be randomly assigned to one of two groups.

Participants in the first group will receive 10 IU oxytocin intravenously at the delivery of the baby's anterior shoulder. Participants in the second group will receive 10 IU oxytocin injected into the umbilical cord after the baby is delivered.

In both groups, the placenta will be delivered using controlled cord traction. Blood loss will be measured by collecting blood in a kidney tray and by weighing pre-weighed sanitary pads for the first 24 hours after delivery.

Researchers will compare the average blood loss between the two groups to determine which method of administering oxytocin is more effective in reducing postpartum bleeding.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Pakistan
    • Punjab Province
      • Multan, Punjab Province, Pakistan, 60000
        • CMH Multan Institute of Medical Sciences

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

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Gestational age 36 - 42 weeks (on LMP)
  • In spontaneous labour

Exclusion Criteria:

  • Chronic hypertension
  • Pre-eclampsia
  • Multiple pregnancies
  • Preterm or postdates pregnancy
  • Previous cesarean section
  • Diabetes (chronic and gestational)
  • Fetal macrosomia
  • History of bleeding / clotting disorder
  • History of anti-coagulation heparin / warfarin therapy
  • Non-reassuring cardiotocograph or poor progress of labour

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Intravenous Oxytocin
Women in this group will receive 10 IU oxytocin administered intravenously at the delivery of the anterior shoulder of the baby during the third stage of labor.
Medicin: Oxytocin after delivery
10 IU oxytocin diluted in normal saline administered slowly via intravenous route at the time of delivery of the anterior shoulder to facilitate uterine contraction and reduce blood loss.
Eksperimentel: Intraumbilical Oxytocin
Women in this group will receive 10 IU oxytocin administered through the umbilical vein after delivery of the baby during the third stage of labor.
Medicin: Intraumbilical oxytocin
10 IU oxytocin diluted in 10 mL normal saline injected into the umbilical vein approximately 2 cm from the introitus after delivery of the baby, with the solution gently milked toward the placental insertion to promote placental separation and reduce blood loss.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Blood Loss During the Third Stage of Labor and Within the First 24 Hours After Vaginal Delivery
Tidsramme: From delivery of the baby until 24 hours postpartum
The average amount of blood lost after delivery will be measured in milliliters. Blood loss will be collected in a kidney tray immediately after delivery and quantified using a graduated cylinder. Additional blood loss during the first 24 hours postpartum will be measured using pre-weighed sanitary pads (1 gram weight increase = 1 mL blood loss).
From delivery of the baby until 24 hours postpartum

Samarbejdspartnere og efterforskere

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

Sponsor

CMH Multan Institute of Medical Sciences

Efterforskere

  • Studiestol: Nidda Y Assistant Professor, FCPS, CMH Multan Institute of Medical Sciences

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)

13. august 2025

Primær færdiggørelse (Faktiske)

12. februar 2026

Studieafslutning (Faktiske)

12. februar 2026

Datoer for studieregistrering

Først indsendt

28. april 2026

Først indsendt, der opfyldte QC-kriterier

28. april 2026

Først opslået (Faktiske)

5. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • U1111-1339-8043

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Oxytocin

Kliniske forsøg med Oxytocin after delivery

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