Prolonged LaborPhase 2AOALNCT02318121
Amniotomy and Oxytocin for Augmentation of Labour
A Phase 2 study testing Amniotomy first, Oxytocin first and Amniotomy and oxytocin in people with Prolonged Labor, run by Assiut University.
Trial summary
Prolonged labour is a cause of maternal mortality and morbidity and perinatal mortality and morbidity. Prolonged labour is most often defined as onset of regular , rhythmical painful contractions accompanied by cervical dilatation where labour is longer than 24 hours.prolonged active phase should not last longer than… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Prolonged Labor
- What is being tested?
- Amniotomy first, Oxytocin first and Amniotomy and oxytocin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2014to 1 Dec 2015
- Phase
- Phase 2
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women in spontaneous labor
- Women with intact membranes at the time of randomization
- Single fetus
- Vertex presentation
- Cervical dilatation 3 cm or more
- Gestational age 37 weeks or more proved by reliable dates or by early ultrasound scan in the first trimester
- Slow progress in the active phase of labor ( cervical dilatation less than 1 cm \hour)
Who cannot join
- Women with a previous uterine scar
- Severe preeclamptic toxemia
- Suspected fetal macrosomia (greater than 4000 g)
- Women with any congenital malformations
- Women with Intra uterine fetal death
- Diabetes mellitus with pregnancy
- Antepartum hemorrhage
- Women with other indications of caesarean section
About this study
Official title: Concurrent Versus Sequential Administration of Amniotomy and Oxytocin for Augmentation of Labour: a Randomized Controlled Trial
Prolonged labour is a cause of maternal mortality and morbidity and perinatal mortality and morbidity. Prolonged labour is most often defined as onset of regular , rhythmical painful contractions accompanied by cervical dilatation where labour is longer than 24 hours.prolonged active phase should not last longer than 12 hours without full assessment in a facility able to offer management and treatment of complications.Causes of prolonged labour usually due to poor or uncoordinated uterine action , fetal head malposition , and or abnormal pelvis either due to bone or soft tissue obstruction.
Arrested or prolonged labor is a frequent indication of cesarean delivery.Prolonged labor is also associated with increased pain and negative birth experience. Women with a prolonged first stage of labor have experienced a higher rate of postpartum hemorrhage, chorioamnionitis and neonatal admission to the intensive care unit.
Read more
Caesarean section rates are over 20% in many developed countries and have increased nearly four-fold relative to the 5% rate observed in the early 1970s. The main diagnosis contributing to this increase is dystocia or prolonged labor.Data obtained from local hospital records showed that Caesarean section rate in Assiut University Women's Health Hospital is 47.96% at 2013.
Dystocia is a term used for delay of labor progress and usually refers to abnormally slow cervical dilatation.It has been proposed that the partogram should include, as a diagnostic criterion, a 1 cm/hour line originating at admission. The World Health Organization has proposed a modified partogram that recommends that active phase be diagnosed only at 4 cm or more.
Oxytocin augmentation of uterine contractions with or without amniotomy is widely used in the modern obstetric practice to treat a slow labour, although the timing of oxytocin initiation and amniotomy may vary widely.This intervention is based on the hypothesis that the most frequent cause of dystocia is inadequate uterine contraction.
The mechanism by which amniotomy speeds up labour remains unclear it is thought that when the membranes are ruptured ,the production and release of prostaglandins and oxytocin increases resulting in stronger contractions and quicker cervical dilatation. I has been found that early intervention (augmentation versus routine care ) with amniotomy and oxytocin to be associated with a modest reduction in the risk of caesarean section. Moreover, amniotomy found to be associated with an increased risk of cesarean delivery compared with women without amniotomy for shortening of spontaneous labour.
The 3 methods ( Amniotomy, Oxytocin or both) used for augmentation of labor in different settings without a real conclusion which is better.
- Conditions
- Prolonged Labor
- Being tested
- Amniotomy first, Oxytocin first, Amniotomy and oxytocin, Oxytocin
- Keywords
- Labor, prolonged labor, augmentation of labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amniotomy firstProcedure or surgery
rupture of membranes to augment labor
Oxytocin firstProcedure or surgery
Administration of oxytocin to augment labor
Amniotomy and oxytocinProcedure or surgery
Rupture of membranes and administration of oxytocin to augment labor
OxytocinDrug
| Study group | Role | What they receive |
|---|---|---|
| Amniotomy first | Active comparator | Will be done with sterile gloves after insurance that is the baby's head fits in the pelvis ( 3\5 or less of fetal head felt by first pelvic grip ) and by vaginal examination the head at station zero . The membranes are then punctured using an a hook during uterine contractions. Receives: Procedure: Amniotomy first |
| Oxytocin first | Active comparator | The starting dose will be the low dose rate equal or less than 4 m unit\minute (4 drops\minute doubled every 15 minutes up to 40 drops \minute) as intravenous drip on dextrose ,Ringer's lactate or saline solution. Receives: Procedure: Oxytocin first; Drug: Oxytocin |
| Amniotomy and oxytocin | Active comparator | Amniotomy will be done (as explained above) and oxytocin (the same regimen mentioned above) at the same time. Receives: Procedure: Amniotomy and oxytocin; Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of cervical dilatation
The rate of cervical dilation cm/ hour
Measured: every hour up to full cervical dilatation
Secondary outcomes (2)
Augmentation delivery time
the duration between Augmentation of labor and the end of the second stage if labor
Measured: Time ( in minutes) between the start of augmentation of labor up to the delivery of the head
Apgar score at 10 minutes
Assessment of Apgar score of the baby at 10 minutes after delivery
Measured: from 0-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study start1 Apr 2014
- Primary completion1 Sep 2014
- Study completion1 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged LaborStudies of the same condition, open and under way.
- More trials run by Assiut 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Mamdouh Shaaban, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318121
- Sponsor's protocol ID
- Augmentation of labour
- Acronym
- AOAL
- Status last verified
- Nov 2017
- First submitted
- 5 Oct 2014
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Versus Sequential Administration of Amniotomy and Oxytocin for Augmentation of Labour: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02318121
- Acronym / sponsor ID
- AOAL / Augmentation of labour
- Conditions
- Prolonged Labor
- Keywords
- Labor, prolonged labor, augmentation of labor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2014
- Primary completion
- 1 Sep 2014 (actual)
- Study completion
- 1 Dec 2015 (actual)
- First posted
- 17 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.
Prolonged labour is a cause of maternal mortality and morbidity and perinatal mortality and morbidity. Prolonged labour is most often defined as onset of regular , rhythmical painful contractions accompanied by cervical dilatation where labour is longer than 24 hours.prolonged active phase should not last longer than 12 hours without full assessment in a facility able to offer management and treatment of complications.Causes of prolonged labour usually due to poor or uncoordinated uterine action , fetal head malposition , and or abnormal pelvis either due to bone or soft tissue obstruction.
Arrested or prolonged labor is a frequent indication of cesarean delivery.Prolonged labor is also associated with increased pain and negative birth experience. Women with a prolonged first stage of labor have experienced a higher rate of postpartum hemorrhage, chorioamnionitis and neonatal admission to the intensive care unit.
Caesarean section rates are over 20% in many developed countries and have increased nearly four-fold relative to the 5% rate observed in the early 1970s. The main diagnosis contributing to this increase is dystocia or prolonged labor.Data obtained from local hospital records showed that Caesarean section rate in Assiut University Women's Health Hospital is 47.96% at 2013.
Dystocia is a term used for delay of labor progress and usually refers to abnormally slow cervical dilatation.It has been proposed that the partogram should include, as a diagnostic criterion, a 1 cm/hour line originating at admission. The World Health Organization has proposed a modified partogram that recommends that active phase be diagnosed only at 4 cm or more.
Oxytocin augmentation of uterine contractions with or without amniotomy is widely used in the modern obstetric practice to treat a slow labour, although the timing of oxytocin initiation and amniotomy may vary widely.This intervention is based on the hypothesis that the most frequent cause of dystocia is inadequate uterine contraction.
The mechanism by which amniotomy speeds up labour remains unclear it is thought that when the membranes are ruptured ,the production and release of prostaglandins and oxytocin increases resulting in stronger contractions and quicker cervical dilatation. I has been found that early intervention (augmentation versus routine care ) with amniotomy and oxytocin to be associated with a modest reduction in the risk of caesarean section. Moreover, amniotomy found to be associated with an increased risk of cesarean delivery compared with women without amniotomy for shortening of spontaneous labour.
The 3 methods ( Amniotomy, Oxytocin or both) used for augmentation of labor in different settings without a real conclusion which is better.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amniotomy first | Active comparator | Procedure: Amniotomy firstWill be done with sterile gloves after insurance that is the baby's head fits in the pelvis ( 3\5 or less of fetal head felt by first pelvic grip ) and by vaginal examination the head at station zero . The membranes are then punctured using an a hook during uterine contractions. |
| Oxytocin first | Active comparator | Procedure: Oxytocin first, Drug: OxytocinThe starting dose will be the low dose rate equal or less than 4 m unit\minute (4 drops\minute doubled every 15 minutes up to 40 drops \minute) as intravenous drip on dextrose ,Ringer's lactate or saline solution. |
| Amniotomy and oxytocin | Active comparator | Procedure: Amniotomy and oxytocin, Drug: OxytocinAmniotomy will be done (as explained above) and oxytocin (the same regimen mentioned above) at the same time. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women in spontaneous labor
- Women with intact membranes at the time of randomization
- Single fetus
- Vertex presentation
- Cervical dilatation 3 cm or more
Key exclusion criteria (8 listed)
- Women with a previous uterine scar
- Severe preeclamptic toxemia
- Suspected fetal macrosomia (greater than 4000 g)
- Women with any congenital malformations
- Women with Intra uterine fetal death
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 |
|---|---|---|
| Amniotomy firstrupture of membranes to augment labor | Procedure or surgery | Amniotomy first |
| Oxytocin firstAdministration of oxytocin to augment labor | Procedure or surgery | Oxytocin first |
| Amniotomy and oxytocinRupture of membranes and administration of oxytocin to augment labor | Procedure or surgery | Amniotomy and oxytocin |
| Oxytocin | Drug | Amniotomy and oxytocin, Oxytocin first |
Primary outcome
Rate of cervical dilatation
Time frame: every hour up to full cervical dilatation
The rate of cervical dilation cm/ hour
2 secondary outcomes
Augmentation delivery time
Time frame: Time ( in minutes) between the start of augmentation of labor up to the delivery of the head
Apgar score at 10 minutes
Time frame: from 0-10 minutes
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 21 Nov 2017.
Related trials for Prolonged Labor
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Not yet recruiting
Predicting Declines in Attention and Memory During a Prolonged Mental Task
Mental Fatigue, Cognitive Performance
Recruiting
Maternal Maneuvers During Prolonged Labor
Labor Stage, First, Prolonged Labor
Not yet recruitingObservational study
Predictors of Prolonged Mechanical Ventilation in Preterm Infants
Premature Birth, Respiration Failure
RecruitingPhase 4
Prolonged Progesterone to Prevent Preterm Birth From IVF - ET
Preterm Birth
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amniotomy first, Oxytocin first and Amniotomy and oxytocin in people with Prolonged Labor, run by Assiut University.
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 7 inclusion and 8 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 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 hour up to full cervical dilatation). 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 21 Nov 2017.