PregnancyNCT02393144
Analysis of Contemporary Labor Patterns Measured Via Transperineal Ultrasonography
A study testing Transperineal ultrasonography, General Electric Healthcare Voluson Ultrasound System, Cardiotocography, Bionet FC1400 Fetal Monitor and Amniotomy in people with Pregnancy and Obstetric Labor, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Primary aim of this study is to analyse contemporary labor patterns by measuring rate of dilatation and head descent via transperineal ultrasonography. Labor curves will be generated using data regarding rate of dilatation, head-descent obtained via transperineal ultrasonography. Read more about this study
- Who is it for?
- Ages 16 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Obstetric Labor
- What is being tested?
- Transperineal ultrasonography, General Electric Healthcare Voluson Ultrasound System, Cardiotocography, Bionet FC1400 Fetal Monitor and Amniotomy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2015to Mar 2017
- Phase
- Interventional
- 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 16 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Term pregnancies
- Spontaneous labor
- Induced labor
Who cannot join
- Preterm pregnancy
- Previous cesarean section
- Fetal presentation anomalies (breech etc.)
- 5th minute APGAR score lower than 7
- Instrumental delivery (forceps or vacuum use)
- Labor management that is not in accordance with "Safe Prevention of the Primary Cesarean Delivery" guideline by American College of Obstetrics and Gynecology.
- Fetus suffering visible birth trauma (laceration, fracture etc.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology
Ankara, 06100
Erkan Kalafat, ekalafat@ankara.edu.tr
About this study
Primary aim of this study is to analyse contemporary labor patterns by measuring rate of dilatation and head descent via transperineal ultrasonography. Labor curves will be generated using data regarding rate of dilatation, head-descent obtained via transperineal ultrasonography. Factors which are known to effect duration of labor will be taken into account.
Read the detailed description
Intrapartum sonography is rapidly advancing field in the management of obstetrics labor. Traditional approach to labor management consists evaluation of cervical dilatation, head position and head descent via digital examinations. Rate of progress is evaluated using data of available labor curves. Unsatisfactory progression is either treated with labor augmentation or cesarean section depending on the degree and duration of labor retardation. Transperineal ultrasonography is able to assess cervical dilatation, fetal head descent and head position. Data obtained from analysis of labor via transperineal ultrasonography is not available. This research's primary aim is to generate labor curves using data obtained via ultrasonographic measurements.
- Conditions
- Pregnancy, Obstetric Labor
- Being tested
- Transperineal ultrasonography, General Electric Healthcare Voluson Ultrasound System, Cardiotocography, Bionet FC1400 Fetal Monitor, Amniotomy, Analgesics, Opioid, Meperidine, Labor augmentation, Oxytocin
- Keywords
- Labor analysis, Transperineal ultrasound imaging, Labor curve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transperineal ultrasonography, General Electric Healthcare Voluson Ultrasound SystemDevice
Assessment of cervical dilatation, angle of progression and head position via transperineal ultrasonography
Cardiotocography, Bionet FC1400 Fetal MonitorDevice
Assessment of strength of uterine contractions (Montevideo units) and fetal heart rate (beat per minute) with electronic monitors.
AmniotomyOther
Artificial rupture of membranes to assess meconium staining and induce labor speed.
Analgesics, Opioid, MeperidineDrug
Administration of meperidine for labor analgesia.
Labor augmentation, OxytocinDrug
Oxytocin infusion for augmentation of labor.
Labor induction, OxytocinDrug
Oxytocin infusion for induction of labor.
Cervical ripening, labor induction, DinoprostoneDrug
Administration of dinoprostone pessary for cervical ripening and labor induction.
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous labor arm | Other | Women with term pregnancies whose labor started spontaneously. Spontaneous labor is determined by either spontaneous rupture of membranes at term and/or powerful, regular uterine contractions that cause cervical change. Women will be admitted to labor ward after initial assessment via transperineal ultrasonography. Labor augmentation will be performed for women with inadequate uterine contractions, i.e. contractions measuring less than Montevideo units, irregular weak uterine contractions. Analgesia will be provided via administration of 50 mg intramuscular meperidine at 2 hour intervals as required. Amniotomy will be performed for women with adequate cervical dilatation and fetal head-descent. Transperineal ultrasonography will be performed at irregular intervals to assess cervical dilatation, angle of progression and fetal head position. After birth, birth time, birth weight, APGAR scores, degree of perineal trauma, episiotomy use will be recorded. Receives: Device: Transperineal ultrasonography, General Electric Healthcare Voluson Ultrasound System; Device: Cardiotocography, Bionet FC1400 Fetal Monitor; Other: Amniotomy; Drug: Analgesics, Opioid, Meperidine; Drug: Labor augmentation, Oxytocin |
| Induced labor arm | Other | Women with term pregnancies who are induced for birth before the onset of spontaneous labor. Labor will be induced with either oxytocin infusion for women with high Bishop score, or labor will be induced with dinoprostone pessary for women requiring cervical ripening, i.e. poor. Women will be admitted to labor ward after initial assessment via transperineal ultrasonography. Analgesia will be provided via administration of 50 mg intramuscular meperidine at 2 hour intervals as required. Amniotomy will be performed for women with adequate cervical dilatation and fetal head-descent. Transperineal ultrasonography will be performed at irregular intervals to assess cervical dilatation, angle of progression and fetal head position. After birth, birth time, birth weight, APGAR scores, degree of perineal trauma, episiotomy use will be recorded. Receives: Device: Transperineal ultrasonography, General Electric Healthcare Voluson Ultrasound System; Device: Cardiotocography, Bionet FC1400 Fetal Monitor; Other: Amniotomy; Drug: Analgesics, Opioid, Meperidine; Drug: Labor induction, Oxytocin; Drug: Cervical ripening, labor induction, Dinoprostone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of active labor
Duration of active labor will be calculated in minutes, in a reverse fashion, beginning from time of birth and going back to first time of measurement.
Measured: From time of initial admission until the time of birth, up to 36 hours
Rate of cervical dilatation advancement as measured by transperineal ultrasonography
Rate of cervical dilatation assessment will be measured in millimetres/hour in a reverse fashion beginning from the time when maximum dilatation is achieved and going back to time of first measurement.
Measured: From time of initial admission until the time of birth, up to 36 hours
Rate of angle of progression advancement as measured by transperineal ultrasonography
Rate of angle of progression advancement will be measured in metric degree in a reverse fashion beginning from the last measurement taken and going back to first measurement taken.
Measured: From time of initial admission until the time of birth, up to 36 hours
Secondary outcomes (1)
Effect of amniotomy on duration of active labor
Effect of amniotomy on the duration of labor will be assessed in minutes by analysing the different time points in different labor processes when amniotomy has taken place.
Measured: From time of initial admission until the time of birth, up to 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- Middle East Technical University
- Responsible party
- Principal investigator, Erkan Kalafat, Ankara University
- Investigators
- Acar F Koc, Professor, Study director, Department of Obstetrics and Gynecology, Ankara University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393144
- Sponsor's protocol ID
- 001
- Status last verified
- Mar 2015
- First submitted
- 22 Feb 2015
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Contemporary Labor Patterns Measured Via Transperineal Ultrasonography
- ClinicalTrials.gov ID
- NCT02393144
- Acronym / sponsor ID
- 001
- Conditions
- Pregnancy, Obstetric Labor
- Keywords
- Labor analysis, Transperineal ultrasound imaging, Labor curve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- Middle East Technical University
- Study start
- Feb 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 19 Mar 2015 (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.
Primary aim of this study is to analyse contemporary labor patterns by measuring rate of dilatation and head descent via transperineal ultrasonography. Labor curves will be generated using data regarding rate of dilatation, head-descent obtained via transperineal ultrasonography. Factors which are known to effect duration of labor will be taken into account.
Detailed description
Intrapartum sonography is rapidly advancing field in the management of obstetrics labor. Traditional approach to labor management consists evaluation of cervical dilatation, head position and head descent via digital examinations. Rate of progress is evaluated using data of available labor curves. Unsatisfactory progression is either treated with labor augmentation or cesarean section depending on the degree and duration of labor retardation. Transperineal ultrasonography is able to assess cervical dilatation, fetal head descent and head position. Data obtained from analysis of labor via transperineal ultrasonography is not available. This research's primary aim is to generate labor curves using data obtained via ultrasonographic measurements.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spontaneous labor arm | Other | Device: Transperineal ultrasonography, General Electric Healthcare Voluson Ultrasound System, Device: Cardiotocography, Bionet FC1400 Fetal Monitor, Other: Amniotomy, Drug: Analgesics, Opioid, Meperidine, Drug: Labor augmentation, OxytocinWomen with term pregnancies whose labor started spontaneously. Spontaneous labor is determined by either spontaneous rupture of membranes at term and/or powerful, regular uterine contractions that cause cervical change. Women will be admitted to labor ward after initial assessment via transperineal ultrasonography. Labor augmentation will be performed for women with inadequate uterine contractions, i.e. contractions measuring less than Montevideo units, irregular weak uterine contractions. Analgesia will be provided via administration of 50 mg intramuscular meperidine at 2 hour intervals as required. Amniotomy will be performed for women with adequate cervical dilatation and fetal head-descent. Transperineal ultrasonography will be performed at irregular intervals to assess cervical dilatation, angle of progression and fetal head position. After birth, birth time, birth weight, APGAR scores, degree of perineal trauma, episiotomy use will be recorded. |
| Induced labor arm | Other | Device: Transperineal ultrasonography, General Electric Healthcare Voluson Ultrasound System, Device: Cardiotocography, Bionet FC1400 Fetal Monitor, Other: Amniotomy, Drug: Analgesics, Opioid, Meperidine, Drug: Labor induction, Oxytocin, Drug: Cervical ripening, labor induction, DinoprostoneWomen with term pregnancies who are induced for birth before the onset of spontaneous labor. Labor will be induced with either oxytocin infusion for women with high Bishop score, or labor will be induced with dinoprostone pessary for women requiring cervical ripening, i.e. poor. Women will be admitted to labor ward after initial assessment via transperineal ultrasonography. Analgesia will be provided via administration of 50 mg intramuscular meperidine at 2 hour intervals as required. Amniotomy will be performed for women with adequate cervical dilatation and fetal head-descent. Transperineal ultrasonography will be performed at irregular intervals to assess cervical dilatation, angle of progression and fetal head position. After birth, birth time, birth weight, APGAR scores, degree of perineal trauma, episiotomy use will be recorded. |
Who may qualify
- Ages
- 16 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Term pregnancies
- Spontaneous labor
- Induced labor
Key exclusion criteria (7 listed)
- Preterm pregnancy
- Previous cesarean section
- Fetal presentation anomalies (breech etc.)
- 5th minute APGAR score lower than 7
- Instrumental delivery (forceps or vacuum use)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transperineal ultrasonography, General Electric Healthcare Voluson Ultrasound SystemAssessment of cervical dilatation, angle of progression and head position via transperineal ultrasonography | Device | Induced labor arm, Spontaneous labor arm |
| Cardiotocography, Bionet FC1400 Fetal MonitorAssessment of strength of uterine contractions (Montevideo units) and fetal heart rate (beat per minute) with electronic monitors. | Device | Induced labor arm, Spontaneous labor arm |
| AmniotomyArtificial rupture of membranes to assess meconium staining and induce labor speed. | Other | Induced labor arm, Spontaneous labor arm |
| Analgesics, Opioid, MeperidineAdministration of meperidine for labor analgesia. | Drug | Induced labor arm, Spontaneous labor arm |
| Labor augmentation, OxytocinOxytocin infusion for augmentation of labor. | Drug | Spontaneous labor arm |
| Labor induction, OxytocinOxytocin infusion for induction of labor. | Drug | Induced labor arm |
| Cervical ripening, labor induction, DinoprostoneAdministration of dinoprostone pessary for cervical ripening and labor induction. | Drug | Induced labor arm |
Primary outcome
Duration of active labor
Time frame: From time of initial admission until the time of birth, up to 36 hours
Duration of active labor will be calculated in minutes, in a reverse fashion, beginning from time of birth and going back to first time of measurement.
Rate of cervical dilatation advancement as measured by transperineal ultrasonography
Time frame: From time of initial admission until the time of birth, up to 36 hours
Rate of cervical dilatation assessment will be measured in millimetres/hour in a reverse fashion beginning from the time when maximum dilatation is achieved and going back to time of first measurement.
Rate of angle of progression advancement as measured by transperineal ultrasonography
Time frame: From time of initial admission until the time of birth, up to 36 hours
Rate of angle of progression advancement will be measured in metric degree in a reverse fashion beginning from the last measurement taken and going back to first measurement taken.
1 secondary outcome
Effect of amniotomy on duration of active labor
Time frame: From time of initial admission until the time of birth, up to 36 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
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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.
Acar F Koc, Professor study director
Department of Obstetrics and Gynecology, Ankara University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transperineal ultrasonography, General Electric Healthcare Voluson Ultrasound System, Cardiotocography, Bionet FC1400 Fetal Monitor and Amniotomy in people with Pregnancy and Obstetric Labor, run by Ankara University at 1 site in Turkey (Türkiye).
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Mar 2015. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erkan Kalafat, M.D (905334736998, ekalafat@ankara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of active labor (time frame: From time of initial admission until the time of birth, up to 36 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2015.