Labor ComplicationSOFIENCT06261710
Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations
A study testing Sonography in labour in people with Labor Complication, run by Larry Hinkson at 1 site in Germany.
Trial summary
This is a prospective, randomized trial to determine whether the use of sonographic parameters during labor results in less intrapartum infection compared to traditional invasive examination. Other secondary outcomes include maternal satisfaction and overall birth outcomes. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Complication
- What is being tested?
- Sonography in labour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteGermany
- Study dates
- 27 Feb 2024to 1 Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women of at least 18 years of age with a singleton in the cephalic position
- Spontaneous onset of labor; births after induction of labor with otherwise suitable inclusion and exclusion criteria are also permitted.
Who cannot join
- Emergency situations such as maternal or fetal bleeding
- Indication for urgent delivery by caesarean section
- Pathological cardiotocogram
- non-cephalic positions
- under 18 years of age
- women giving birth who are unable to give consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité University Hospital
Berlin
Larry Hinkson, FRCOG
About this study
This is a prospective, randomized trial to determine whether the use of sonographic parameters during labor results in less intrapartum infection compared to traditional invasive examination. Other secondary outcomes include maternal satisfaction and overall birth outcomes.
Read the detailed description
It is a prospective, randomized trial to determine whether the use of sonographic parameters during childbirth results in less intrapartum infection compared to traditional invasive examination. Intrapartum non-invasive ultrasound has been established and validated as a method of assessing labor progress. Guidelines from international societies recommend the use of ultrasound to monitor labor and support decision-making during delivery. Despite its reproducibility and reliability, there is no comprehensive work to date demonstrating the potential benefit in reducing clinical chorioamnionitis compared to traditional invasive vaginal examination. With this in mind, the investigators set out to analyze the clinical benefit of using ultrasound alone using established non-invasive, intrapartum, translabial parameters (Angle of Progression, Head Perineum Distance, Midline Angle, Cervix Dilatation) to monitor birth outcomes compared to traditional invasive vaginal examinations.
Primary Outcome is the incidence of clinical chorioamnionitis. Secondary Outcome measures include mode of delivery and neonatal outcomes such as neonatal admission.
- Conditions
- Labor Complication
- Being tested
- Sonography in labour
- Keywords
- Chorioamnionitis, Sonography
- Medical subject headings
- Obstetric Labor Complications, Chorioamnionitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonography in labourOther
Using intrapartum sonography parameters in labour
| Study group | Role | What they receive |
|---|---|---|
| Sonography Only | Experimental | The use of ultrasound parameters to asses the progress of labour from admission to delivery. Namely, Angle of Progression, Head Perineum Distance, Midline Angle and Cervix Dilatation at 3-4 hour intervals until delivery. Receives: Other: Sonography in labour |
| Traditional | No intervention | The traditional use of internal vaginal examination to assess cervix dilatation, fetal head position, station and orientation within the pelvis during the course of labour as routinely performed every 3-4 hours in labour and until delivery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Fever Incidence
Percentage. Incidence of Fever >37.8°C measured with a thermometer in patients within the group
Measured: In the course of labour from admission until delivery in 3-4 hour intervals
Maternal Tachycardia Incidence
Percentage. Incidence of >100 beats per minute as maternal pulse measurement in patients within the group
Measured: In the course of labour from admission until delivery in 3-4 hour intervals
Maternal Leucocytosis
Percentage. Incidence of maternal leucocytosis (white blood cell count >15,000 leukocytes per microliter of blood) in patients within the group
Measured: In the course of labour from admission until delivery in 6 hour intervals
Uterine tenderness
Percentage. The incidence of uterine tenderness on palpation during the course of labour in patients within the group
Measured: In the course of labour from admission until delivery 3-4 hour intervals
Fetal Tachycardia
Percentage.The incidence of fetal tachycardia (>160 beats per minute) on continuous Cardiotocographic Monitoring in patients within the group
Measured: In the course of labour from admission until delivery
Foul-smelling amniotic fluid
Percentage . The incidence of foul-smelling amniotic fluid on clinical examination in patients with in the group
Measured: In the course of labour from admission until delivery
Secondary outcomes (13)
Average age
Number (years) measured per patient and the average within the group.
Measured: Upon admission for delivery
Maternal weight
Number (kilograms) measured per patient and the average within the group.
Measured: Upon admission for delivery
Maternal height
Number (centimetres) measured per patient and the average within the group.
Measured: Upon admission for delivery
Completed weeks of pregnancy
Number (weeks) measured per patient and the average within the group.
Measured: Upon admission for delivery
Previous pregnancy
Number measured per patient and the average within the group.
Measured: Upon admission for delivery
Incidence of Vaginal Examinations
Percentage. The number of vaginal examinations performed in labour on average per patient within the group.
Measured: In the course of labour until delivery
Incidence of Caesarean section
Percentage.The incidence of Caesarean section (No. of Cesareans as a percentage of the Group total)
Measured: In the course of labour until delivery
Incidence of Instrumental Delivery
Percentage.The incidence of instrumental deliveries (No. of instrumental deliveries as a percentage of the total in the group)
Measured: In the course of labour until delivery
Incidence of estimated blood loss >1000 ml
Percentage.The incidence of estimated blood loss >1000 millilitres (No. of cases as a percentage of the total in the group)
Measured: In the course of labour until delivery and up to 24 hours postpartum
Incidence of antibiotics usage
Percentage.The incidence of antibiotic use (No. of cases as a percentage of the total in the group)
Measured: In the course of labour until delivery and up to 24 hours postpartum
Incidence of Neonatal Admission
Percentage. The incidence of neonatal admission in patients within the groups
Measured: Up to 6 weeks postpartum
Neonatal weight
Number. Gramms measures on weighing on a scale
Measured: Up to 30 Minutes after birth
Maternal Satisfaction Scores
Linkert scores. Questionnaire on maternal views on the use of examination in labour. (Linkert scores from 1-6 with increasing scale)
Measured: On admission and after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start27 Feb 2024 (estimated)
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Labor ComplicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Larry Hinkson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Larry Hinkson, Charite University, Berlin, Germany
- Investigators
- Larry Hinkson, FRCOG, Principal investigator, Charité University Hospital Department of Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261710
- Sponsor's protocol ID
- EA2_253_23
- Acronym
- SOFIE
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tita AT, Andrews WW. Diagnosis and management of clinical chorioamnionitis. Clin Perinatol. 2010 Jun;37(2):339-54. doi: 10.1016/j.clp.2010.02.003.
PubMed 20569811Ghi T, Eggebo T, Lees C, Kalache K, Rozenberg P, Youssef A, Salomon LJ, Tutschek B. ISUOG Practice Guidelines: intrapartum ultrasound. Ultrasound Obstet Gynecol. 2018 Jul;52(1):128-139. doi: 10.1002/uog.19072.
PubMed 29974596
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations
- ClinicalTrials.gov ID
- NCT06261710
- Acronym / sponsor ID
- SOFIE / EA2_253_23
- Conditions
- Labor Complication
- Keywords
- Chorioamnionitis, Sonography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- Larry HinksonUniversity, hospital or other
- Study start
- 27 Feb 2024 (estimated)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 15 Feb 2024 (actual)
- 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.
This is a prospective, randomized trial to determine whether the use of sonographic parameters during labor results in less intrapartum infection compared to traditional invasive examination. Other secondary outcomes include maternal satisfaction and overall birth outcomes.
Detailed description
It is a prospective, randomized trial to determine whether the use of sonographic parameters during childbirth results in less intrapartum infection compared to traditional invasive examination. Intrapartum non-invasive ultrasound has been established and validated as a method of assessing labor progress. Guidelines from international societies recommend the use of ultrasound to monitor labor and support decision-making during delivery. Despite its reproducibility and reliability, there is no comprehensive work to date demonstrating the potential benefit in reducing clinical chorioamnionitis compared to traditional invasive vaginal examination. With this in mind, the investigators set out to analyze the clinical benefit of using ultrasound alone using established non-invasive, intrapartum, translabial parameters (Angle of Progression, Head Perineum Distance, Midline Angle, Cervix Dilatation) to monitor birth outcomes compared to traditional invasive vaginal examinations.
Primary Outcome is the incidence of clinical chorioamnionitis. Secondary Outcome measures include mode of delivery and neonatal outcomes such as neonatal admission.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sonography Only | Experimental | Other: Sonography in labourThe use of ultrasound parameters to asses the progress of labour from admission to delivery. Namely, Angle of Progression, Head Perineum Distance, Midline Angle and Cervix Dilatation at 3-4 hour intervals until delivery. |
| Traditional | No intervention | –The traditional use of internal vaginal examination to assess cervix dilatation, fetal head position, station and orientation within the pelvis during the course of labour as routinely performed every 3-4 hours in labour and until delivery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women of at least 18 years of age with a singleton in the cephalic position
- Spontaneous onset of labor; births after induction of labor with otherwise suitable inclusion and exclusion criteria are also permitted.
Key exclusion criteria (6 listed)
- Emergency situations such as maternal or fetal bleeding
- Indication for urgent delivery by caesarean section
- Pathological cardiotocogram
- non-cephalic positions
- under 18 years of age
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 |
|---|---|---|
| Sonography in labourUsing intrapartum sonography parameters in labour | Other | Sonography Only |
Primary outcome
Maternal Fever Incidence
Time frame: In the course of labour from admission until delivery in 3-4 hour intervals
Percentage. Incidence of Fever >37.8°C measured with a thermometer in patients within the group
Maternal Tachycardia Incidence
Time frame: In the course of labour from admission until delivery in 3-4 hour intervals
Percentage. Incidence of >100 beats per minute as maternal pulse measurement in patients within the group
Maternal Leucocytosis
Time frame: In the course of labour from admission until delivery in 6 hour intervals
Percentage. Incidence of maternal leucocytosis (white blood cell count >15,000 leukocytes per microliter of blood) in patients within the group
Uterine tenderness
Time frame: In the course of labour from admission until delivery 3-4 hour intervals
Percentage. The incidence of uterine tenderness on palpation during the course of labour in patients within the group
Fetal Tachycardia
Time frame: In the course of labour from admission until delivery
Percentage.The incidence of fetal tachycardia (>160 beats per minute) on continuous Cardiotocographic Monitoring in patients within the group
Foul-smelling amniotic fluid
Time frame: In the course of labour from admission until delivery
Percentage . The incidence of foul-smelling amniotic fluid on clinical examination in patients with in the group
13 secondary outcomes
Average age
Time frame: Upon admission for delivery
Maternal weight
Time frame: Upon admission for delivery
Maternal height
Time frame: Upon admission for delivery
Completed weeks of pregnancy
Time frame: Upon admission for delivery
Previous pregnancy
Time frame: Upon admission for delivery
Incidence of Vaginal Examinations
Time frame: In the course of labour until delivery
Incidence of Caesarean section
Time frame: In the course of labour until delivery
Incidence of Instrumental Delivery
Time frame: In the course of labour until delivery
Incidence of estimated blood loss >1000 ml
Time frame: In the course of labour until delivery and up to 24 hours postpartum
Incidence of antibiotics usage
Time frame: In the course of labour until delivery and up to 24 hours postpartum
Incidence of Neonatal Admission
Time frame: Up to 6 weeks postpartum
Neonatal weight
Time frame: Up to 30 Minutes after birth
Maternal Satisfaction Scores
Time frame: On admission and after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Background: PubMed 20569811Tita AT, Andrews WW. Diagnosis and management of clinical chorioamnionitis. Clin Perinatol. 2010 Jun;37(2):339-54. doi: 10.1016/j.clp.2010.02.003.
- Background: PubMed 29974596Ghi T, Eggebo T, Lees C, Kalache K, Rozenberg P, Youssef A, Salomon LJ, Tutschek B. ISUOG Practice Guidelines: intrapartum ultrasound. Ultrasound Obstet Gynecol. 2018 Jul;52(1):128-139. doi: 10.1002/uog.19072.
- Individual participant dataSharing planned: No
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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.
Larry Hinkson, FRCOG principal investigator
Charité University Hospital Department of Obstetrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonography in labour in people with Labor Complication, run by Larry Hinkson at 1 site in Germany.
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 6 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: looking for participants now, as of the sponsor's last update on 16 Feb 2024. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Larry Hinkson, FRCOG (030450664710, Larry.Hinkson@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Fever Incidence (time frame: In the course of labour from admission until delivery in 3-4 hour intervals). The study lists 6 primary outcomes in all. 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 NCT06261710, which also lists 2 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 16 Feb 2024.