Obstetric Labor ComplicationsNCT04888871
Comparison of Prevention and Appropiate Obstetric Interventions for Prolonged Second Stage Labor at Term Pregnancies During Vaginal Delivery
An observational study of Obstetric Labor Complications and Vacuum Extraction; Failure, Affecting Fetus or Newborn, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Randomized Control Trial for Comparison of Prevention and Appropiate Obstetric Interventions for Prolonged Second Stage Labor at Term Pregnancies During Vaginal Delivery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Obstetric Labor Complications, Vacuum Extraction; Failure, Affecting Fetus or Newborn, Complicated Labour/Delivery Livebirth
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 31 May 2021
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Randomized Control Trial for Comparison of Prevention and Appropiate Obstetric Interventions for Prolonged Second Stage Labor at Term Pregnancies During Vaginal Delivery.
Who may be able to join
- term pregnancy weeks between 37-42, singleton, vertex presentations
- prolonged second stage of labor
- Fetal head is minimum at the level of ischial spin
- maternal incompatibility during/after second stage of labor
- complete cervical dilatation
Who cannot join
- Fetal distress
- Uncomplete cervical dilatation
- twin pregnancies or polycyesia
- Pregnancy weeks lower than 37weeks
- other than vertex presentations
- Fetal Anomalies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zeynep Kamil Maternity and Childrens Hospital
Istanbul, Uskudar, 34660
Resul Karakus, MD, +905059164216, resul-karakus@hotmail.com
About this study
Official title: Randomized Control Trial for Comparison of Prevention and Appropiate Obstetric Interventions for Prolonged Second Stage Labor at Term Pregnancies During Vaginal Delivery
Randomized Control Trial for Comparison of Prevention and Appropiate Obstetric Interventions for Prolonged Second Stage Labor at Term Pregnancies During Vaginal Delivery.
Read the detailed description
This study includes prolonged second stage phase and not prolonged second phase in pregnant women to singletons at the weeks between 37-42. Fetal head level will be at or below the ischial spines in all patients.Patients with fully dilated cervix will be included in the study and the bladder will be emptied completely on the labor table. Patients diagnosed with fetal distress will not be included in the study.Indicated patients will be randomly divided into three groups; one group will be only subjected to a Fundal Pressure (Kristaller Maneuver), second group will only be subjected to Vacuum Extraction and the third group will be subjected to both Fundal Pressure (Kristaller Maneuver) and Vacuum Extraction. Maternal episiotomy needs presence of second and third degree perineal tears, presence of postpartum hemorrhage and need for blood transfusion , cesarean rates and fetal first and fifth minute Apgar score , fetal blood gas parameters, presence of fetal trauma, need for neonatal intensive care will be evaluated among three randomized groups.
- Conditions
- Obstetric Labor Complications, Vacuum Extraction; Failure, Affecting Fetus or Newborn, Complicated Labour/Delivery Livebirth
- Keywords
- labor stage, second
- Medical subject headings
- Obstetric Labor Complications, Neoplasm Metastasis
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 |
|---|---|---|
| Only Fundal Pressure (Kristeller Maneuver) | prolonged second stage phase and not prolonged second phase in pregnant women to singletons at the weeks between 37-42, applying Only Fundal Pressure (Kristeller Maneuver) and the postpartum evaluation of maternal episiotomy needs presence of second and third degree perineal tears, presence of postpartum hemorrhage and need for blood transfusion , cesarean rates and fetal first and fifth minute Apgar score , fetal blood gas parameters, presence of fetal trauma, need for neonatal intensive care will | |
| Only Vacuum Extraction | prolonged second stage phase and not prolonged second phase in pregnant women to singletons at the weeks between 37-42, applying only vacuum extraction and the postpartum evaluation of maternal episiotomy needs presence of second and third degree perineal tears, presence of postpartum hemorrhage and need for blood transfusion , cesarean rates and fetal first and fifth minute Apgar score , fetal blood gas parameters, presence of fetal trauma, need for neonatal intensive care will | |
| Both Fundal Pressure (Kristeller Maneuver) and Vacuum Extraction | prolonged second stage phase and not prolonged second phase in pregnant women to singletons at the weeks between 37-42, applying Both Fundal Pressure (Kristeller Maneuver) and Vacuum Extraction and the postpartum evaluation of maternal episiotomy needs presence of second and third degree perineal tears, presence of postpartum hemorrhage and need for blood transfusion , cesarean rates and fetal first and fifth minute Apgar score , fetal blood gas parameters, presence of fetal trauma, need for neonatal intensive care will |
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal morbidity
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Feb 2020
- Primary completion1 Aug 2020
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric Labor ComplicationsStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Resul Karakuş, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888871
- Sponsor's protocol ID
- 2020/123
- Status last verified
- May 2021
- First submitted
- 11 May 2021
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial for Comparison of Prevention and Appropiate Obstetric Interventions for Prolonged Second Stage Labor at Term Pregnancies During Vaginal Delivery
- ClinicalTrials.gov ID
- NCT04888871
- Acronym / sponsor ID
- 2020/123
- Conditions
- Obstetric Labor Complications, Vacuum Extraction; Failure, Affecting Fetus or Newborn, Complicated Labour/Delivery Livebirth
- Keywords
- labor stage, second
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 17 May 2021 (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.
Randomized Control Trial for Comparison of Prevention and Appropiate Obstetric Interventions for Prolonged Second Stage Labor at Term Pregnancies During Vaginal Delivery.
Detailed description
This study includes prolonged second stage phase and not prolonged second phase in pregnant women to singletons at the weeks between 37-42. Fetal head level will be at or below the ischial spines in all patients.Patients with fully dilated cervix will be included in the study and the bladder will be emptied completely on the labor table. Patients diagnosed with fetal distress will not be included in the study.Indicated patients will be randomly divided into three groups; one group will be only subjected to a Fundal Pressure (Kristaller Maneuver), second group will only be subjected to Vacuum Extraction and the third group will be subjected to both Fundal Pressure (Kristaller Maneuver) and Vacuum Extraction. Maternal episiotomy needs presence of second and third degree perineal tears, presence of postpartum hemorrhage and need for blood transfusion , cesarean rates and fetal first and fifth minute Apgar score , fetal blood gas parameters, presence of fetal trauma, need for neonatal intensive care will be evaluated among three randomized groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Only Fundal Pressure (Kristeller Maneuver) | – | –prolonged second stage phase and not prolonged second phase in pregnant women to singletons at the weeks between 37-42, applying Only Fundal Pressure (Kristeller Maneuver) and the postpartum evaluation of maternal episiotomy needs presence of second and third degree perineal tears, presence of postpartum hemorrhage and need for blood transfusion , cesarean rates and fetal first and fifth minute Apgar score , fetal blood gas parameters, presence of fetal trauma, need for neonatal intensive care will |
| Only Vacuum Extraction | – | –prolonged second stage phase and not prolonged second phase in pregnant women to singletons at the weeks between 37-42, applying only vacuum extraction and the postpartum evaluation of maternal episiotomy needs presence of second and third degree perineal tears, presence of postpartum hemorrhage and need for blood transfusion , cesarean rates and fetal first and fifth minute Apgar score , fetal blood gas parameters, presence of fetal trauma, need for neonatal intensive care will |
| Both Fundal Pressure (Kristeller Maneuver) and Vacuum Extraction | – | –prolonged second stage phase and not prolonged second phase in pregnant women to singletons at the weeks between 37-42, applying Both Fundal Pressure (Kristeller Maneuver) and Vacuum Extraction and the postpartum evaluation of maternal episiotomy needs presence of second and third degree perineal tears, presence of postpartum hemorrhage and need for blood transfusion , cesarean rates and fetal first and fifth minute Apgar score , fetal blood gas parameters, presence of fetal trauma, need for neonatal intensive care will |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Randomized Control Trial for Comparison of Prevention and Appropiate Obstetric Interventions for Prolonged Second Stage Labor at Term Pregnancies During Vaginal Delivery.
Key inclusion criteria (5 listed)
- term pregnancy weeks between 37-42, singleton, vertex presentations
- prolonged second stage of labor
- Fetal head is minimum at the level of ischial spin
- maternal incompatibility during/after second stage of labor
- complete cervical dilatation
Key exclusion criteria (6 listed)
- Fetal distress
- Uncomplete cervical dilatation
- twin pregnancies or polycyesia
- Pregnancy weeks lower than 37weeks
- other than vertex presentations
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
maternal morbidity
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- 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. This study is not recruiting at the moment.
Zeynep Kamil Maternity and Childrens Hospital
Istanbul, Turkey (Türkiye)
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 Obstetric Labor Complications and Vacuum Extraction; Failure, Affecting Fetus or Newborn, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital 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 5 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: status not confirmed, as of the sponsor's last update on 17 May 2021. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maternal morbidity (time frame: 3 months). 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 17 May 2021.