Postpartum HemorrhagePhase 1NCT02680938
Prophylactic Use of Intraumbilical Vein Oxytocin Injection in The Management of Third Stage of Labor
A Phase 1 study testing oxytocin and saline in people with Postpartum Hemorrhage, run by Ain Shams University at 1 site in Egypt.
Trial summary
The third stage is the interval between delivery of the infant and delivery of the placenta. This stage averages 10 minutes and is considered prolonged if it lasts longer than 30 minutes, placental separation occurs as a result of continued uterine contractions, continued contractions control blood loss by compression… Read more about this study
- Who is it for?
- Ages 14 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- oxytocin and saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Mar 2016
- Phase
- Phase 1
- 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 14 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 36 to 42 weeks gestational age.
- Single alive fetus with cephalic presentation.
- Parity 1 to 3.
- Normal vaginal delivery.
Who cannot join
- Placenta Previa.
- Placental Abruption .
- Prolonged Labor ( > 20 h )
- History of Postpartum Hemorrhage or Antepartum Hemorrhage.
- History of Cesarean delivery or any uterine scar .
- Polyhydramnios .
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- Known uterine anomalies.
- Coagulation disorders.
- Abnormal placental adhesion.
- Forceps or Vacuum delivery.
- Chorioamninitis.
- Multiple Gestations.
- Accelerated Labor (< 3 h ).
- Painless Labor with Epidural Anaethesia
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
kareem Sami mostafa
Cairo, Cairo Governorate, 113311
kareem S mostafa, dockimo1@hotmail.com
About this study
Official title: Prophylactic Use of Intraumbilical Vein Oxytocin Injection in The Management of Third Stage of Labor A Randomized Controlled Study
The third stage is the interval between delivery of the infant and delivery of the placenta. This stage averages 10 minutes and is considered prolonged if it lasts longer than 30 minutes, placental separation occurs as a result of continued uterine contractions, continued contractions control blood loss by compression of spiral arteries and also result in migration of the placenta into the lower uterine segment and then through the cervix.
The intra-umbilical vein injection of 10 IU of oxytocin is recommended as a first line of treatment for retained placenta. Despite this recommendation, the method has yet to make its way into routine practice, probably because of the lack of a large substantive randomized controlled trial, and lingering doubts over which uterotonic to use and at what dosage.
Read more
The purpose of this study is to evaluate the effect of intraumbilical vein injection of oxytocin on reducing the duration of the third stage of labor and the need for manual delivery of placenta, ,in addition to reduce blood loss during third and fourth stage of labor and decrease incidence of rtained placenta in comparison with inraumblical injection of normal saline.
This is a prospective randomized control trial conducted at Ain Shams University Maternity Hospital. This study included 240 term pregnant women in labor admitted to the labor ward, They were divided into Two groups :
Group (A):
The experimental group, 10 units of oxytocin will be injected into the umbilical vein at the most proximal site to the placenta after clamping and cutting of the umbilical cord.
Group (B):
The control group, 1 mL normal saline will be injected into the umbilical vein at the most proximal site to the placenta after clamping and cutting of the umbilical cord.
Read the detailed description
This study included 240 term pregnant women in labor admitted to the labor ward, They were divided into Two groups :
Group (A):
The experimental group, 10 units of oxytocin will be injected into the umbilical vein at the most proximal site to the placenta after clamping and cutting of the umbilical cord.
Group (B):
The control group, 1 mL normal saline will be injected into the umbilical vein at the most proximal site to the placenta after clamping and cutting of the umbilical cord.
complete blood count of both groups before and 12 h after delivery.
- The third stage of labor will be actively managed in the two groups by infusion of 20 IU oxytocin in 1 L Ringer's lactate solution at a rate of 100 mL/min, immediately after delivery of the fetus ( Nankali et al., 2013)..
- In the control group ( B ) , 1 mL normal saline will be injected into the umbilical vein at the most proximal site to the placenta after clamping and cutting of the umbilical cord.
- In the experimental group ( A ) , instead of normal saline, 10 IU (1mL) oxytocin will be injected at the same site. We will wait 30 min for the symptoms of placenta delivery (i.e., the uterus became firmer and more globular and was displaced upward, a gush of blood occurred, and the umbilical cord was elongated).
- Spontaneous delivery of the placenta will be achieved by touching the fundus and applying pressure on the symphysis pubis by a finger and slight traction of the umbilical cord.
- For each participant, the duration of the third stage of labor (the time period between the delivery of the fetus and the delivery of the placenta) will be recorded.
- The two groups will be compared in the following terms:
- The duration of the third stage of labor by stopwatch.
- Hemoglobin (Hb) difference before and 12 h after delivery.
- The need for manual delivery of the placenta. Manual removal of the placenta will be commonly carried out under general sedation in the operating room, if the placenta will not be delivered 30 min after fetal delivery.
- Estimate blood loss by Allowable Blood Loss (ABL) (Miller 2000)
- Conditions
- Postpartum Hemorrhage
- Being tested
- oxytocin, saline
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxytocinDrug
Also called syntocinon
For each participant, the duration of the third stage of labor (the time period between the delivery of the fetus and the delivery of the placenta) will be recorded.
- The two groups will be compared in the following terms:
- The duration of the third stage of labor by stopwatch.
- Hemoglobin (Hb) difference before and 12 h after delivery.
- The need for manual delivery of the placenta. Manual removal of the placenta will be commonly carried out under general sedation in the operating room, if the placenta will not be delivered 30 min after fetal delivery.
salineDrug
Also called placebo
For each participant, the duration of the third stage of labor (the time period between the delivery of the fetus and the delivery of the placenta) will be recorded.
- The two groups will be compared in the following terms:
- The duration of the third stage of labor by stopwatch.
- Hemoglobin (Hb) difference before and 12 h after delivery.
- The need for manual delivery of the placenta. Manual removal of the placenta will be commonly carried out under general sedation in the operating room, if the placenta will not be delivered 30 min after fetal delivery.
| Study group | Role | What they receive |
|---|---|---|
| oxytocin group | Active comparator | 10 units of oxytocin will be injected into the umbilical vein at the most proximal site to the placenta after clamping and cutting of the umbilical cord. Receives: Drug: oxytocin |
| control group | Placebo comparator | 1 mL normal saline will be injected into the umbilical vein at the most proximal site to the placenta after clamping and cutting of the umbilical cord. Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the third stage of labor.
For each participant, the duration of the third stage of labor (the time period between the delivery of the fetus and the delivery of the placenta) will be recorded.
Measured: more than 30 minutes, we will do manual separation of placenta
Secondary outcomes (1)
Hb difference before and 12 h after delivery.
Measured: before labor and after 12 hours after delievery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startJan 2015
- Primary completionFeb 2016
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kareem Sami mostafa, Ain Shams University
- Investigators
- kareem S mostafa, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680938
- Sponsor's protocol ID
- gyn-057
- Status last verified
- Mar 2016
- First submitted
- 4 Feb 2016
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The aim of the present study was to evaluate the effect of intraumbilical vein oxytocin on reducing the duration of the third stage of labor and the need for manual delivery of placenta, in comparison with normal saline administration
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Use of Intraumbilical Vein Oxytocin Injection in The Management of Third Stage of Labor A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02680938
- Acronym / sponsor ID
- gyn-057
- Conditions
- Postpartum Hemorrhage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (estimated)
- First posted
- 12 Feb 2016 (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.
The third stage is the interval between delivery of the infant and delivery of the placenta. This stage averages 10 minutes and is considered prolonged if it lasts longer than 30 minutes, placental separation occurs as a result of continued uterine contractions, continued contractions control blood loss by compression of spiral arteries and also result in migration of the placenta into the lower uterine segment and then through the cervix.
The intra-umbilical vein injection of 10 IU of oxytocin is recommended as a first line of treatment for retained placenta. Despite this recommendation, the method has yet to make its way into routine practice, probably because of the lack of a large substantive randomized controlled trial, and lingering doubts over which uterotonic to use and at what dosage.
The purpose of this study is to evaluate the effect of intraumbilical vein injection of oxytocin on reducing the duration of the third stage of labor and the need for manual delivery of placenta, ,in addition to reduce blood loss during third and fourth stage of labor and decrease incidence of rtained placenta in comparison with inraumblical injection of normal saline.
This is a prospective randomized control trial conducted at Ain Shams University Maternity Hospital. This study included 240 term pregnant women in labor admitted to the labor ward, They were divided into Two groups :
Group (A):
The experimental group, 10 units of oxytocin will be injected into the umbilical vein at the most proximal site to the placenta after clamping and cutting of the umbilical cord.
Group (B):
The control group, 1 mL normal saline will be injected into the umbilical vein at the most proximal site to the placenta after clamping and cutting of the umbilical cord.
Detailed description
This study included 240 term pregnant women in labor admitted to the labor ward, They were divided into Two groups :
Group (A):
The experimental group, 10 units of oxytocin will be injected into the umbilical vein at the most proximal site to the placenta after clamping and cutting of the umbilical cord.
Group (B):
The control group, 1 mL normal saline will be injected into the umbilical vein at the most proximal site to the placenta after clamping and cutting of the umbilical cord.
complete blood count of both groups before and 12 h after delivery.
- The third stage of labor will be actively managed in the two groups by infusion of 20 IU oxytocin in 1 L Ringer's lactate solution at a rate of 100 mL/min, immediately after delivery of the fetus ( Nankali et al., 2013)..
- In the control group ( B ) , 1 mL normal saline will be injected into the umbilical vein at the most proximal site to the placenta after clamping and cutting of the umbilical cord.
- In the experimental group ( A ) , instead of normal saline, 10 IU (1mL) oxytocin will be injected at the same site. We will wait 30 min for the symptoms of placenta delivery (i.e., the uterus became firmer and more globular and was displaced upward, a gush of blood occurred, and the umbilical cord was elongated).
- Spontaneous delivery of the placenta will be achieved by touching the fundus and applying pressure on the symphysis pubis by a finger and slight traction of the umbilical cord.
- For each participant, the duration of the third stage of labor (the time period between the delivery of the fetus and the delivery of the placenta) will be recorded.
- The two groups will be compared in the following terms:
- The duration of the third stage of labor by stopwatch.
- Hemoglobin (Hb) difference before and 12 h after delivery.
- The need for manual delivery of the placenta. Manual removal of the placenta will be commonly carried out under general sedation in the operating room, if the placenta will not be delivered 30 min after fetal delivery.
- Estimate blood loss by Allowable Blood Loss (ABL) (Miller 2000)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxytocin group | Active comparator | Drug: oxytocin10 units of oxytocin will be injected into the umbilical vein at the most proximal site to the placenta after clamping and cutting of the umbilical cord. |
| control group | Placebo comparator | Drug: saline1 mL normal saline will be injected into the umbilical vein at the most proximal site to the placenta after clamping and cutting of the umbilical cord. |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 36 to 42 weeks gestational age.
- Single alive fetus with cephalic presentation.
- Parity 1 to 3.
- Normal vaginal delivery.
Key exclusion criteria (14 listed)
- Placenta Previa.
- Placental Abruption .
- Prolonged Labor ( > 20 h )
- History of Postpartum Hemorrhage or Antepartum Hemorrhage.
- History of Cesarean delivery or any uterine scar .
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 |
|---|---|---|
| oxytocinAlso: syntocinonFor each participant, the duration of the third stage of labor (the time period between the delivery of the fetus and the delivery of the placenta) will be recorded. - The two groups will be compared in the following terms: 1. The duration of the third stage of labor by stopwatch. 2. Hemoglobin (Hb) difference before and 12 h after delivery. 3. The need for manual delivery of the placenta. Manual removal of the placenta will be commonly carried out under general sedation in the operating room, if the placenta will not be delivered 30 min after fetal delivery. | Drug | oxytocin group |
| salineAlso: placeboFor each participant, the duration of the third stage of labor (the time period between the delivery of the fetus and the delivery of the placenta) will be recorded. - The two groups will be compared in the following terms: 1. The duration of the third stage of labor by stopwatch. 2. Hemoglobin (Hb) difference before and 12 h after delivery. 3. The need for manual delivery of the placenta. Manual removal of the placenta will be commonly carried out under general sedation in the operating room, if the placenta will not be delivered 30 min after fetal delivery. | Drug | control group |
Primary outcome
Duration of the third stage of labor.
Time frame: more than 30 minutes, we will do manual separation of placenta
For each participant, the duration of the third stage of labor (the time period between the delivery of the fetus and the delivery of the placenta) will be recorded.
1 secondary outcome
Hb difference before and 12 h after delivery.
Time frame: before labor and after 12 hours after delievery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
- Individual participant dataSharing planned: Yes. The aim of the present study was to evaluate the effect of intraumbilical vein oxytocin on reducing the duration of the third stage of labor and the need for manual delivery of placenta, in comparison with normal saline administration
Related trials for Postpartum Hemorrhage
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Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
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Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
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Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
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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.
kareem S mostafa principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing oxytocin and saline in people with Postpartum Hemorrhage, run by Ain Shams University at 1 site in Egypt.
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 14 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 2 Mar 2016. 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 Egypt. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 kareem S mostafa (01288102018, dockimo1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of the third stage of labor. (time frame: more than 30 minutes, we will do manual separation of placenta). 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 2 Mar 2016.