Normal LaborSONOLABORNCT02326077
Sonopartogram. The Next Step in the Delivery Room
An observational study of Normal Labor and Obstetric Labor Complications, run by University of Medicine and Pharmacy Craiova at 2 sites in 2 countries.
Trial summary
Objectives: Evaluation of the correlation between the sonographic parameter and clinical findings (e.g. digital examination) in any cephalic (not only occipital anterior) position Examination of the relationship between various sonographic parameters Determination of intraobserver and interobserver variation in… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Normal Labor, Obstetric Labor Complications
- What is being tested?
- Ultrasound, Acceptability of ultrasound monitoring of labor and Patients' experience regarding intrapartum ultrasound
- How many people
- 4,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2020to 31 Oct 2023
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The pregnant women admitted in active labor at term were considered eligible for the study. They are included in the study consecutively, depending on the availability of the US operators involved.
Who may be able to join
- active labor
- singleton pregnancy
- eutrophic fetus
- cephalic presentation
Who cannot join
- indication for elective caesarean section
- non-cephalic presentation
- prior caesarean delivery
- fetal hypotrophy or macrosomy
- multiple pregnancies
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Intrapartum Ultrasonography - Sonopartogram. Longitudinal Evaluation of the Mechanism of Active Labor Using Ultrasound Parameters
Objectives:
- Evaluation of the correlation between the sonographic parameter and clinical findings (e.g. digital examination) in any cephalic (not only occipital anterior) position
- Examination of the relationship between various sonographic parameters
- Determination of intraobserver and interobserver variation in obtaining the sonographic measurements
- Analysis of the temporal variation of the different sonographic measurements in normal spontaneous vaginal delivery versus obstructed labor in fetuses with occiput anterior versus those with persistent occiput posterior
- Establishment of a sonopartogram that should replace in an objective way Friedmann
- Establishment of cut-off values that may help clinicians to choose between vaginal operative delivery or caesarean section
- Another interesting aspect of intrapartum transperineal ultrasound imaging is whether there is a psychological benefit to the patient in being able to follow on the ultrasound screen how fetal head descent and position are being assessed objectively.
Read the detailed description
Objectives:
- Evaluation of the correlation between the sonographic parameter and clinical findings (e.g. digital examination) in any cephalic (not only occipital anterior)
- Examination of the relationship between various sonographic parameters
- Determination of intraobserver and interobserver variation in obtaining the sonographic measurements
- Analysis of the temporal variation of the different sonographic measurements in normal spontaneous vaginal delivery versus obstructed labor in fetuses with occiput anterior versus those with persistent occiput posterior
- Establishment of a sonopartogram that should replace in an objective way Friedmann
- Determination of cut-off values that may help clinicians to choose between vaginal operative delivery or caesarean section
- Investigation whether there is a psychological benefit to the patient in being able to follow on the ultrasound screen how fetal head descent and position are being assessed objectively.
Methods:
Unselected population Personal characteristics: GA, BMI, age, gesta, para Gestational age of more than 37 completed weeks dated by first- and/or mid-trimester scan.
Each patient provide informed consent before the ultrasound measurements. Transperineal ultrasound imaging and digital examinations in laboring patients with a singleton fetus in cephalic/pelvic presentation. Patients examined in their labor rooms.
Admission time:
- active labor demonstrated by regular uterine contractions and changes in cervical dilatation of more than 2 cm,
- subgroup: prolonged second stage of labor (full cervical dilatation for >3 h if regional anesthesia was administered or 2 h in the absence of regional anesthesia in nulliparous women, or for >2 h with regional anesthesia or 1 h without anesthesia in parous women).
Empty bladder. Ultrasound machine with a 3.5-5MHz transducer used for the TA and TPU measurements. The probe enclosed in a latex glove covered with ultrasound gel and was then placed between the labia below the pubic symphysis/perineal.
Measured parameters:
Clinical examination (digital vaginal + Leopold) followed immediately after by the acquisition of the sonographic planes necessary to evaluate:occiput position, the long axis of the pubic symphysis, the infrapubic line, the progression angle, the distance of progession, the direction of progression, the midline angle, the head to perineum distance.
Identification and measurement of caput succedaneum (vertical+orizontal) and molding (vertical) when present.
All parameters recorded electronically for later analysis + volumes, when possible.
TPU scans performed at different times during labor,
- Hourly until complete dilation (1st phase)
- At 10 minutes after complete dilation (2nd phase) (at least one contraction between the examinations).
Notation of time delivery later used to calculate the interval from scanning to delivery.
In all cases measurements are performed in concert with digital examinations (immediately after).
Intraobserver and interobserver analysis 100 women assessed by TPU examination in the study, have at least one set of two replicated scans obtained at approximately the same time. These women provide sets of scans at various times throughout labor, used to assess intraobserver variability.
In order to assess interobserver variability, a second/independent and well trained observer, blinded to the other's results,
- obtain duplicate sets of scans at distinct times of labor among randomly selected women (one woman repeated at three time points). The consecutive scans performed with no more than 3 min between the assessments of the two observers
- or measuring the parameters stored on 3D volumes by the first observer The goal is to generate paired sets of replicated images under nearly identical conditions.
The measurements from the ultrasound scanning are obtained offline, after the acquisition of the described planes, on the images stored on the US machine hard disk.
Thus, the managing obstetrician is blinded to the transperineal ultrasound findings. Head position obtained by ultrasound imaging is communicated in case of clinical misdiagnose because of ethical reasons.
The decision whether expectant management, vaginal extraction or Cesarean section is appropriate is made exclusively on the basis of clinical examination.
Demographic data are collected including length of the second stage of labor, mode of delivery, maternal and neonatal outcome.
- Conditions
- Normal Labor, Obstetric Labor Complications
- Being tested
- Ultrasound, Acceptability of ultrasound monitoring of labor, Patients' experience regarding intrapartum ultrasound
- Keywords
- sonopartogram, transperineal ultrasound, intrapartum ultrasound, labor, delivery, partogram, ultrasound
- Medical subject headings
- Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundOther
Monitoring of the mechanism of labor
Acceptability of ultrasound monitoring of laborOther
Evaluation of the acceptability of intrapartum ultrasound monitoring - the rate of uptake ultrasound protocol during labor
Patients' experience regarding intrapartum ultrasoundOther
The day after birth, consenting women are invited to take part in a questionnaire survey. Questionnaires contained no identifying information other than a code number and contains features regarding the patient's impression about the ultrasound monitoring scans during labor. The final questions concerned the willingness of having again another such protocol for labor monitoring in the future.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Clinical evaluation in active labor: Leopold manoeuvres, vaginal digital examination.
Transabdominal and transperineal ultrasound evaluations of the mechanism of labor: fetal head position, progression and rotation.
Investigation by questionnaire regarding the psychological impact of labor monitoring assisted by sonoraphy. Receives: Other: Ultrasound; Other: Acceptability of ultrasound monitoring of labor; Other: Patients' experience regarding intrapartum ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sonopartogram. Longitudinal assessment of the mechanism of labor using ultrasound parameters.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion31 Oct 2023 (estimated)
Why it stopped: Equipment and personnel discontinuity
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Normal LaborStudies of the same condition, open and under way.
- 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy Craiova
- Sponsor type
- University, hospital or other
- Collaborators
- University of Athens
- Responsible party
- Sponsor
- Investigators
- Nicolae Cernea, Professor, Study chair, University of Medicine and Pharmacy CraiovaDominic G Iliescu, Lecturer, Study director, University of Medicine and Pharmacy CraiovaStefania Tudorache, Lecturer, Principal investigator, University of Medicine and Pharmacy Craiova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326077
- Sponsor's protocol ID
- SONOPARTOGRAM
- Acronym
- SONOLABOR
- Status last verified
- Mar 2020
- First submitted
- 20 Dec 2014
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Zhang J, Troendle JF, Yancey MK. Reassessing the labor curve in nulliparous women. Am J Obstet Gynecol. 2002 Oct;187(4):824-8. doi: 10.1067/mob.2002.127142.
PubMed 12388957Rayburn WF, Siemers KH, Legino LJ, Nabity MR, Anderson JC, Patil KD. Dystocia in late labor: determining fetal position by clinical and ultrasonic techniques. Am J Perinatol. 1989 Jul;6(3):316-9. doi: 10.1055/s-2007-999602.
PubMed 2659012Kreiser D, Schiff E, Lipitz S, Kayam Z, Avraham A, Achiron R. Determination of fetal occiput position by ultrasound during the second stage of labor. J Matern Fetal Med. 2001 Aug;10(4):283-6. doi: 10.1080/714904341.
PubMed 11531156Sherer DM, Miodovnik M, Bradley KS, Langer O. Intrapartum fetal head position I: comparison between transvaginal digital examination and transabdominal ultrasound assessment during the active stage of labor. Ultrasound Obstet Gynecol. 2002 Mar;19(3):258-63. doi: 10.1046/j.1469-0705.2002.00641.x.
PubMed 11896947Sherer DM, Miodovnik M, Bradley KS, Langer O. Intrapartum fetal head position II: comparison between transvaginal digital examination and transabdominal ultrasound assessment during the second stage of labor. Ultrasound Obstet Gynecol. 2002 Mar;19(3):264-8. doi: 10.1046/j.1469-0705.2002.00656.x.
PubMed 11896948Akmal S, Tsoi E, Kametas N, Howard R, Nicolaides KH. Intrapartum sonography to determine fetal head position. J Matern Fetal Neonatal Med. 2002 Sep;12(3):172-7. doi: 10.1080/jmf.12.3.172.177.
PubMed 12530614Souka AP, Haritos T, Basayiannis K, Noikokyri N, Antsaklis A. Intrapartum ultrasound for the examination of the fetal head position in normal and obstructed labor. J Matern Fetal Neonatal Med. 2003 Jan;13(1):59-63. doi: 10.1080/jmf.13.1.59.63.
PubMed 12710859Iliescu DG, Adam G, Tudorache S, Antsaklis P, Cernea N. Quantification of fetal head direction using transperineal ultrasound: an easier approach. Ultrasound Obstet Gynecol. 2012 Nov;40(5):607-8. doi: 10.1002/uog.11117. Epub 2012 Sep 24. No abstract available.
PubMed 22302748Hassan WA, Eggebo T, Ferguson M, Gillett A, Studd J, Pasupathy D, Lees CC. The sonopartogram: a novel method for recording progress of labor by ultrasound. Ultrasound Obstet Gynecol. 2014 Feb;43(2):189-94. doi: 10.1002/uog.13212.
PubMed 24105734Eggebo TM. Ultrasound is the future diagnostic tool in active labor. Ultrasound Obstet Gynecol. 2013 Apr;41(4):361-3. doi: 10.1002/uog.12417. No abstract available.
PubMed 23641509FRIEDMAN EA. Primigravid labor; a graphicostatistical analysis. Obstet Gynecol. 1955 Dec;6(6):567-89. doi: 10.1097/00006250-195512000-00001. No abstract available.
PubMed 13272981Tutschek B, Braun T, Chantraine F, Henrich W. A study of progress of labour using intrapartum translabial ultrasound, assessing head station, direction, and angle of descent. BJOG. 2011 Jan;118(1):62-9. doi: 10.1111/j.1471-0528.2010.02775.x. Epub 2010 Nov 18.
PubMed 21083864Dira LM, Tudorache S, Antsaklis P, Daskalakis G, Themistoklis D, Belciug S, Stoean R, Novac M, Cara ML, Dragusin R, Florea M, Patru C, Zorila L, Nagy R, Ruican D, Iliescu DG. Sonographic Evaluation of the Mechanism of Active Labor (SonoLabor Study): observational study protocol regarding the implementation of the sonopartogram. BMJ Open. 2021 Sep 7;11(9):e047188. doi: 10.1136/bmjopen-2020-047188.
PubMed 34493509
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrapartum Ultrasonography - Sonopartogram. Longitudinal Evaluation of the Mechanism of Active Labor Using Ultrasound Parameters
- ClinicalTrials.gov ID
- NCT02326077
- Acronym / sponsor ID
- SONOLABOR / SONOPARTOGRAM
- Conditions
- Normal Labor, Obstetric Labor Complications
- Keywords
- sonopartogram, transperineal ultrasound, intrapartum ultrasound, labor, delivery, partogram, ultrasound
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Equipment and personnel discontinuity
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy CraiovaUniversity, hospital or other
- Collaborators
- University of Athens
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 25 Dec 2014 (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.
Objectives:
- Evaluation of the correlation between the sonographic parameter and clinical findings (e.g. digital examination) in any cephalic (not only occipital anterior) position
- Examination of the relationship between various sonographic parameters
- Determination of intraobserver and interobserver variation in obtaining the sonographic measurements
- Analysis of the temporal variation of the different sonographic measurements in normal spontaneous vaginal delivery versus obstructed labor in fetuses with occiput anterior versus those with persistent occiput posterior
- Establishment of a sonopartogram that should replace in an objective way Friedmann
- Establishment of cut-off values that may help clinicians to choose between vaginal operative delivery or caesarean section
- Another interesting aspect of intrapartum transperineal ultrasound imaging is whether there is a psychological benefit to the patient in being able to follow on the ultrasound screen how fetal head descent and position are being assessed objectively.
Detailed description
Objectives:
- Evaluation of the correlation between the sonographic parameter and clinical findings (e.g. digital examination) in any cephalic (not only occipital anterior)
- Examination of the relationship between various sonographic parameters
- Determination of intraobserver and interobserver variation in obtaining the sonographic measurements
- Analysis of the temporal variation of the different sonographic measurements in normal spontaneous vaginal delivery versus obstructed labor in fetuses with occiput anterior versus those with persistent occiput posterior
- Establishment of a sonopartogram that should replace in an objective way Friedmann
- Determination of cut-off values that may help clinicians to choose between vaginal operative delivery or caesarean section
- Investigation whether there is a psychological benefit to the patient in being able to follow on the ultrasound screen how fetal head descent and position are being assessed objectively.
Methods:
Unselected population Personal characteristics: GA, BMI, age, gesta, para Gestational age of more than 37 completed weeks dated by first- and/or mid-trimester scan.
Each patient provide informed consent before the ultrasound measurements. Transperineal ultrasound imaging and digital examinations in laboring patients with a singleton fetus in cephalic/pelvic presentation. Patients examined in their labor rooms.
Admission time:
- active labor demonstrated by regular uterine contractions and changes in cervical dilatation of more than 2 cm,
- subgroup: prolonged second stage of labor (full cervical dilatation for >3 h if regional anesthesia was administered or 2 h in the absence of regional anesthesia in nulliparous women, or for >2 h with regional anesthesia or 1 h without anesthesia in parous women).
Empty bladder. Ultrasound machine with a 3.5-5MHz transducer used for the TA and TPU measurements. The probe enclosed in a latex glove covered with ultrasound gel and was then placed between the labia below the pubic symphysis/perineal.
Measured parameters:
Clinical examination (digital vaginal + Leopold) followed immediately after by the acquisition of the sonographic planes necessary to evaluate:occiput position, the long axis of the pubic symphysis, the infrapubic line, the progression angle, the distance of progession, the direction of progression, the midline angle, the head to perineum distance.
Identification and measurement of caput succedaneum (vertical+orizontal) and molding (vertical) when present.
All parameters recorded electronically for later analysis + volumes, when possible.
TPU scans performed at different times during labor,
- Hourly until complete dilation (1st phase)
- At 10 minutes after complete dilation (2nd phase) (at least one contraction between the examinations).
Notation of time delivery later used to calculate the interval from scanning to delivery.
In all cases measurements are performed in concert with digital examinations (immediately after).
Intraobserver and interobserver analysis 100 women assessed by TPU examination in the study, have at least one set of two replicated scans obtained at approximately the same time. These women provide sets of scans at various times throughout labor, used to assess intraobserver variability.
In order to assess interobserver variability, a second/independent and well trained observer, blinded to the other's results,
- obtain duplicate sets of scans at distinct times of labor among randomly selected women (one woman repeated at three time points). The consecutive scans performed with no more than 3 min between the assessments of the two observers
- or measuring the parameters stored on 3D volumes by the first observer The goal is to generate paired sets of replicated images under nearly identical conditions.
The measurements from the ultrasound scanning are obtained offline, after the acquisition of the described planes, on the images stored on the US machine hard disk.
Thus, the managing obstetrician is blinded to the transperineal ultrasound findings. Head position obtained by ultrasound imaging is communicated in case of clinical misdiagnose because of ethical reasons.
The decision whether expectant management, vaginal extraction or Cesarean section is appropriate is made exclusively on the basis of clinical examination.
Demographic data are collected including length of the second stage of labor, mode of delivery, maternal and neonatal outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Other: Ultrasound, Other: Acceptability of ultrasound monitoring of labor, Other: Patients' experience regarding intrapartum ultrasoundClinical evaluation in active labor: Leopold manoeuvres, vaginal digital examination. Transabdominal and transperineal ultrasound evaluations of the mechanism of labor: fetal head position, progression and rotation. Investigation by questionnaire regarding the psychological impact of labor monitoring assisted by sonoraphy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The pregnant women admitted in active labor at term were considered eligible for the study. They are included in the study consecutively, depending on the availability of the US operators involved.
Key inclusion criteria (4 listed)
- active labor
- singleton pregnancy
- eutrophic fetus
- cephalic presentation
Key exclusion criteria (5 listed)
- indication for elective caesarean section
- non-cephalic presentation
- prior caesarean delivery
- fetal hypotrophy or macrosomy
- multiple pregnancies
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 |
|---|---|---|
| UltrasoundMonitoring of the mechanism of labor | Other | Intervention group |
| Acceptability of ultrasound monitoring of laborEvaluation of the acceptability of intrapartum ultrasound monitoring - the rate of uptake ultrasound protocol during labor | Other | Intervention group |
| Patients' experience regarding intrapartum ultrasoundThe day after birth, consenting women are invited to take part in a questionnaire survey. Questionnaires contained no identifying information other than a code number and contains features regarding the patient's impression about the ultrasound monitoring scans during labor. The final questions concerned the willingness of having again another such protocol for labor monitoring in the future. | Other | Intervention group |
Primary outcome
Sonopartogram. Longitudinal assessment of the mechanism of labor using ultrasound parameters.
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Background: PubMed 12388957Zhang J, Troendle JF, Yancey MK. Reassessing the labor curve in nulliparous women. Am J Obstet Gynecol. 2002 Oct;187(4):824-8. doi: 10.1067/mob.2002.127142.
- Background: PubMed 2659012Rayburn WF, Siemers KH, Legino LJ, Nabity MR, Anderson JC, Patil KD. Dystocia in late labor: determining fetal position by clinical and ultrasonic techniques. Am J Perinatol. 1989 Jul;6(3):316-9. doi: 10.1055/s-2007-999602.
- Background: PubMed 11531156Kreiser D, Schiff E, Lipitz S, Kayam Z, Avraham A, Achiron R. Determination of fetal occiput position by ultrasound during the second stage of labor. J Matern Fetal Med. 2001 Aug;10(4):283-6. doi: 10.1080/714904341.
- Background: PubMed 11896947Sherer DM, Miodovnik M, Bradley KS, Langer O. Intrapartum fetal head position I: comparison between transvaginal digital examination and transabdominal ultrasound assessment during the active stage of labor. Ultrasound Obstet Gynecol. 2002 Mar;19(3):258-63. doi: 10.1046/j.1469-0705.2002.00641.x.
- Background: PubMed 11896948Sherer DM, Miodovnik M, Bradley KS, Langer O. Intrapartum fetal head position II: comparison between transvaginal digital examination and transabdominal ultrasound assessment during the second stage of labor. Ultrasound Obstet Gynecol. 2002 Mar;19(3):264-8. doi: 10.1046/j.1469-0705.2002.00656.x.
- Background: PubMed 12530614Akmal S, Tsoi E, Kametas N, Howard R, Nicolaides KH. Intrapartum sonography to determine fetal head position. J Matern Fetal Neonatal Med. 2002 Sep;12(3):172-7. doi: 10.1080/jmf.12.3.172.177.
- Background: PubMed 12710859Souka AP, Haritos T, Basayiannis K, Noikokyri N, Antsaklis A. Intrapartum ultrasound for the examination of the fetal head position in normal and obstructed labor. J Matern Fetal Neonatal Med. 2003 Jan;13(1):59-63. doi: 10.1080/jmf.13.1.59.63.
- Background: PubMed 22302748Iliescu DG, Adam G, Tudorache S, Antsaklis P, Cernea N. Quantification of fetal head direction using transperineal ultrasound: an easier approach. Ultrasound Obstet Gynecol. 2012 Nov;40(5):607-8. doi: 10.1002/uog.11117. Epub 2012 Sep 24. No abstract available.
- Background: PubMed 24105734Hassan WA, Eggebo T, Ferguson M, Gillett A, Studd J, Pasupathy D, Lees CC. The sonopartogram: a novel method for recording progress of labor by ultrasound. Ultrasound Obstet Gynecol. 2014 Feb;43(2):189-94. doi: 10.1002/uog.13212.
- Background: PubMed 23641509Eggebo TM. Ultrasound is the future diagnostic tool in active labor. Ultrasound Obstet Gynecol. 2013 Apr;41(4):361-3. doi: 10.1002/uog.12417. No abstract available.
- Background: PubMed 13272981FRIEDMAN EA. Primigravid labor; a graphicostatistical analysis. Obstet Gynecol. 1955 Dec;6(6):567-89. doi: 10.1097/00006250-195512000-00001. No abstract available.
- Background: PubMed 21083864Tutschek B, Braun T, Chantraine F, Henrich W. A study of progress of labour using intrapartum translabial ultrasound, assessing head station, direction, and angle of descent. BJOG. 2011 Jan;118(1):62-9. doi: 10.1111/j.1471-0528.2010.02775.x. Epub 2010 Nov 18.
- 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.
Nicolae Cernea, Professor study chair
University of Medicine and Pharmacy Craiova
Dominic G Iliescu, Lecturer study director
University of Medicine and Pharmacy Craiova
Stefania Tudorache, Lecturer principal investigator
University of Medicine and Pharmacy Craiova
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Labor and Obstetric Labor Complications, run by University of Medicine and Pharmacy Craiova at 2 sites in 2 countries.
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 4 inclusion and 5 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: paused, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece, Romania. 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?
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?
Sonopartogram. Longitudinal assessment of the mechanism of labor using ultrasound parameters. (time frame: 5 years). 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 NCT02326077, which also lists 13 linked publications.
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 31 Mar 2020.