- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02686073
Effect of Maternal Body Mass Index on Labor Progress in Nulliparous Women
Revising the Norms of Labor Progress in Egyptian Nulliparous Women in Relation to Maternal Body Mass Index Categories
Aperçu de l'étude
Statut
Les conditions
Description détaillée
For nulliparous cases presenting to the labor ward, maternal height & weight will be collected at the time of admission to calculate the BMI (body mass index) & further classified according to WHO (World Health Organization) categories. Putting into consideration the physiological increase in BMI related to pregnancy, the overweight participants whose BMI (25-29.9) will be combined with the normal range BMI (18.5-24.9) category. Labor characteristics of these participants will be then compared with those of the underweight (BMI less than 18.5) & obese (BMI 30 or higher) participants.Females are assigned in one of 3 groups based on their BMI; Underweight group (BMI <18.5kg/m2), Control group whose BMI within normal range (18.5-29.9 kg/m2),& Obese group (BMI more than or equal 30kg/m2).
Labor management protocols are fixed. Data on labor progression are collected, including cervical dilatation, cervical effacement, head station & descent. The median duration of labor , estimated by rate of cervical dilatation in cm, will be used as a measurement of labor progression in each group.
A cesarean section for abnormal labor pattern will be documented as failure of progress.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Greater Cairo
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Cairo, Greater Cairo, Egypte, 11956
- Cairo University
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- nulliparous women in active phase of labor, with an age range from 20 to 40 years.
Full term pregnancy, singleton, viable fetus, cephalic (vertex) presentation, occipito-anterior position.
Exclusion Criteria:
- Multiparous women. Preterm labor. Passed date delivery. Multiple gestation. Large fetal weight (more than 4000g). Intrauterine fetal death. Intrauterine fetal growth restriction. Major fetal congenital anomalies. Rupture of membranes before onset of active labor. Fetal malposition or malpresentation. Inadequate pelvis or cephalopelvic disproportion. Maternal medical disorder.
Induction of labor by oxytocin or prostaglandins. Conditions requiring urgent delivery eg antepartum haemorrhage, fetal distress, cord prolapse.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Group A
Underweight participants whose body mass index is less than 18.5 kg/m2
|
Group B
Control group, in which the participants belong to the normal body mass index range , from 18.5 to 29.9 kg/m2
|
Group C
Obese participants whose body mass index is more than or equal to 30 kg/m2.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
rate of cervical dilatation
Délai: every 2 hours during active phase of labor, from admission to the labor ward until second stage of labor.
|
in centimeters
|
every 2 hours during active phase of labor, from admission to the labor ward until second stage of labor.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
descent of fetal head
Délai: every 2 hours during active phase of labor, from admission to the labor ward until second stage of labor
|
head station
|
every 2 hours during active phase of labor, from admission to the labor ward until second stage of labor
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
duration of active phase of labor
Délai: all through the course of labor, individually assessed for each participant, starting from the time of admission to labor ward until start of second stage of labor
|
total duration in hours
|
all through the course of labor, individually assessed for each participant, starting from the time of admission to labor ward until start of second stage of labor
|
duration of second stage of labor
Délai: from start of second stage of labor ( full cervical dilatation) until delivery of fetus
|
total duration in minutes
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from start of second stage of labor ( full cervical dilatation) until delivery of fetus
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mode of delivery
Délai: labor
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vaginal delivery or cesarean section
|
labor
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Doaa Sh Belal, hospital, Cairo University
Publications et liens utiles
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 (Estimation)
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
- Kasr El-Aini Hospital
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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