- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07686419
Labor Care Guide Application (LCG)
Labor Care Guide Application in Ain Shams University Maternity Hospital: A Randomized Controlled Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
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Cairo, Egypte
- Ain Shams University Maternity Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Labor care guide
Intervensional study
|
labor monitoring tool
|
|
Aucune intervention: partogrph
no intervension
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Healthcare Provider Satisfaction as Measured by the Provider Satisfaction Questionnaire (PSQ)
Délai: assessed at 6 months
|
Measured using a 5-point Likert scale.
Range: 1-5.
Higher scores indicate greater satisfaction.
|
assessed at 6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mode of delivery
Délai: At delivery
|
The percentage of participants undergoing different modes of delivery (e.g., normal vaginal delivery, operative vaginal delivery, or cesarean section)
|
At delivery
|
|
Duration of active labor
Délai: At delivery
|
The total duration of the active phase of labor, measured in hours.
|
At delivery
|
|
Incidence of maternal complications
Délai: assessed at 6 weeks postpartum
|
The percentage of mothers who experience any postpartum or intrapartum complications (e.g., postpartum hemorrhage, infection).
|
assessed at 6 weeks postpartum
|
|
Incidence of neonatal complications
Délai: At delivery
|
The percentage of newborns who experience neonatal complications (e.g., respiratory distress, hypoglycemia).
|
At delivery
|
|
Duration of hospital stay
Délai: from birth until hospital discharge average 2 to 3 days
|
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
|
|
Neonatal Outcomes via Apgar Score and NICU Admission
Délai: from birth until hospital discharge average 2 to 3 days
|
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).
|
from birth until hospital discharge average 2 to 3 days
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- MS459
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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