- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Greater Cairo
-
Cairo, Greater Cairo, Egypten, 11956
- Cairo University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
---|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
rate of cervical dilatation
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
descent of fetal head
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
duration of active phase of labor
Tidsram: 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
Tidsram: from start of second stage of labor ( full cervical dilatation) until delivery of fetus
|
total duration in minutes
|
from start of second stage of labor ( full cervical dilatation) until delivery of fetus
|
mode of delivery
Tidsram: labor
|
vaginal delivery or cesarean section
|
labor
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Doaa Sh Belal, hospital, Cairo University
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- Kasr El-Aini Hospital
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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