- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07686419
Labor Care Guide Application (LCG)
Labor Care Guide Application in Ain Shams University Maternity Hospital: A Randomized Controlled Trial
Studieoversikt
Detaljert beskrivelse
The Labor Care Guide (LCG) is a tool developed by the World Health Organization (WHO) to support evidence-based, woman-centered intrapartum care and improve labor monitoring. It was introduced as an alternative to the traditional partograph, aiming to facilitate timely clinical decision-making and enhance the quality of maternity care.
This randomized controlled trial was conducted at Ain Shams University Maternity Hospital to evaluate the effect of the WHO Labor Care Guide on maternal and neonatal outcomes among women undergoing vaginal delivery. Eligible pregnant women were randomly assigned to one of two groups: a study group monitored using the WHO Labor Care Guide and a control group monitored using the modified WHO partograph.
Participants underwent routine obstetric assessment and monitoring throughout labor according to the allocated monitoring tool. Maternal outcomes assessed included labor progression, mode of delivery, and intrapartum and postpartum complications. Neonatal outcomes included neonatal well-being, need for neonatal intensive care admission, and neonatal complications. Healthcare provider satisfaction with the labor monitoring tool was also evaluated.
The study aimed to compare the effectiveness of the WHO Labor Care Guide with the modified WHO partograph in supporting labor management and improving maternal and neonatal care.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Cairo, Egypt
- Ain Shams University Maternity Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Pregnant woman who will undergo vaginal delivery at Ain Shams University Maternity Hospital with gestational age above or equal 37 weeks
- Vertex presentation .
- Women with estimated fetal weight 2.5 till 4 kg
Exclusion Criteria::
- Placenta previa
- Placenta previa accreta
- Macrosomic baby above 4 kg in diabetic women and above 4.5 kg in non diabetic women
- Placenta abruption complicated by non reassuring CTG or life threatening bleeding
- Cord prolapse
- Vasa previa
- Primary active genital herpes simplex
- Patient with anemia which may lead to atonic uterus and prolonged labor.
- Women with previously scarred uterus due to risk of ruptured uterus and postpartum hemorrhage
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Labor care guide
Intervensional study
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labor monitoring tool
|
|
Ingen inngripen: partogrph
no intervension
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Healthcare Provider Satisfaction as Measured by the Provider Satisfaction Questionnaire (PSQ)
Tidsramme: assessed at 6 months
|
Measured using a 5-point Likert scale.
Range: 1-5.
Higher scores indicate greater satisfaction.
|
assessed at 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mode of delivery
Tidsramme: At delivery
|
The percentage of participants undergoing different modes of delivery (e.g., normal vaginal delivery, operative vaginal delivery, or cesarean section)
|
At delivery
|
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Duration of active labor
Tidsramme: At delivery
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The total duration of the active phase of labor, measured in hours.
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At delivery
|
|
Incidence of maternal complications
Tidsramme: assessed at 6 weeks postpartum
|
The percentage of mothers who experience any postpartum or intrapartum complications (e.g., postpartum hemorrhage, infection).
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assessed at 6 weeks postpartum
|
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Incidence of neonatal complications
Tidsramme: At delivery
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The percentage of newborns who experience neonatal complications (e.g., respiratory distress, hypoglycemia).
|
At delivery
|
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Duration of hospital stay
Tidsramme: from birth until hospital discharge average 2 to 3 days
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The total number of days the mother and/or neonate remained hospitalized from admission to discharge.
|
from birth until hospital discharge average 2 to 3 days
|
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Neonatal Outcomes via Apgar Score and NICU Admission
Tidsramme: from birth until hospital discharge average 2 to 3 days
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Neonatal well-being will be assessed using the Apgar score at 5 minutes (ranging from 0 to 10, where higher scores indicate better neonatal health) and the rate of admission to the Neonatal Intensive Care Unit (NICU).
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from birth until hospital discharge average 2 to 3 days
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- MS459
Plan for individuelle deltakerdata (IPD)
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