Labor ProgressNCT02686073
Effect of Maternal Body Mass Index on Labor Progress in Nulliparous Women
An observational study of Labor Progress, run by Cairo University at 1 site in Egypt.
Trial summary
Study the rate of progress of labor among nulliparous women belonging to different body mass index groups, \& observe how does this variation in maternal body mass index may affect the course of labor. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Progress
- How many people
- 600 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2016to 28 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant nulliparous women, at term, during labor
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Revising the Norms of Labor Progress in Egyptian Nulliparous Women in Relation to Maternal Body Mass Index Categories
Study the rate of progress of labor among nulliparous women belonging to different body mass index groups, \& observe how does this variation in maternal body mass index may affect the course of labor.
Read the detailed description
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.
- Conditions
- Labor Progress
- Keywords
- BMI, progress of labor, nulliparous women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of cervical dilatation
in centimeters
Measured: every 2 hours during active phase of labor, from admission to the labor ward until second stage of labor.
Secondary outcomes (1)
descent of fetal head
head station
Measured: every 2 hours during active phase of labor, from admission to the labor ward until second stage of labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study start20 Feb 2016
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor ProgressStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Shafie Belal, Cairo University
- Investigators
- Doaa Sh Belal, hospital, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686073
- Sponsor's protocol ID
- Kasr El-Aini Hospital
- Status last verified
- Jul 2017
- First submitted
- 7 Feb 2016
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Maged AM, Belal DS, Marie HM, Rashwan H, Abdelaziz S, Gabr AA, Elzayat AR. Prospective study of the effect of maternal body mass index on labor progress in nulliparous women in Egypt. Int J Gynaecol Obstet. 2017 Dec;139(3):329-335. doi: 10.1002/ijgo.12322. Epub 2017 Oct 3.
PubMed 28886213
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revising the Norms of Labor Progress in Egyptian Nulliparous Women in Relation to Maternal Body Mass Index Categories
- ClinicalTrials.gov ID
- NCT02686073
- Acronym / sponsor ID
- Kasr El-Aini Hospital
- Conditions
- Labor Progress
- Keywords
- BMI, progress of labor, nulliparous women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2016 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 19 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study the rate of progress of labor among nulliparous women belonging to different body mass index groups, \& observe how does this variation in maternal body mass index may affect the course of labor.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant nulliparous women, at term, during labor
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
rate of cervical dilatation
Time frame: every 2 hours during active phase of labor, from admission to the labor ward until second stage of labor.
in centimeters
1 secondary outcome
descent of fetal head
Time frame: every 2 hours during active phase of labor, from admission to the labor ward until second stage of labor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
- Derived from this study: PubMed 28886213Maged AM, Belal DS, Marie HM, Rashwan H, Abdelaziz S, Gabr AA, Elzayat AR. Prospective study of the effect of maternal body mass index on labor progress in nulliparous women in Egypt. Int J Gynaecol Obstet. 2017 Dec;139(3):329-335. doi: 10.1002/ijgo.12322. Epub 2017 Oct 3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doaa Sh Belal, hospital principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor Progress, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of cervical dilatation (time frame: every 2 hours during active phase of labor, from admission to the labor ward until second stage of labor.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02686073, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.