- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07686419
Labor Care Guide Application (LCG)
Labor Care Guide Application in Ain Shams University Maternity Hospital: A Randomized Controlled Trial
Studienübersicht
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
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Cairo, Ägypten
- Ain Shams University Maternity Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Labor care guide
Intervensional study
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labor monitoring tool
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Kein Eingriff: partogrph
no intervension
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Healthcare Provider Satisfaction as Measured by the Provider Satisfaction Questionnaire (PSQ)
Zeitfenster: assessed at 6 months
|
Measured using a 5-point Likert scale.
Range: 1-5.
Higher scores indicate greater satisfaction.
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assessed at 6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Mode of delivery
Zeitfenster: At delivery
|
The percentage of participants undergoing different modes of delivery (e.g., normal vaginal delivery, operative vaginal delivery, or cesarean section)
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At delivery
|
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Duration of active labor
Zeitfenster: At delivery
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The total duration of the active phase of labor, measured in hours.
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At delivery
|
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Incidence of maternal complications
Zeitfenster: assessed at 6 weeks postpartum
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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
Zeitfenster: At delivery
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The percentage of newborns who experience neonatal complications (e.g., respiratory distress, hypoglycemia).
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At delivery
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Duration of hospital stay
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- MS459
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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