Postpartum HemorrhagePhase 3NCT02319707
Management of the Third Stage of Labor
A Phase 3 study testing Oxytocin and Oxytocin in 100 ml NaCl 0.9% in people with Postpartum Hemorrhage, run by Yariv yogev.
Trial summary
To compare the efficacy of three different protocols of third stage management in preventing PPH. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Oxytocin and Oxytocin in 100 ml NaCl 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Jan 2017
- Phase
- Phase 3
- 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
Who may be able to join
- Singleton pregnancy.
- 34-41 weeks of gestation.
- Maternal age between 18 and 45.
Who cannot join
- Women who enter delivery room during the active phase of labor (cervical dilatation greater than 5 cm)
- Coagulation defects
- VAS score>3 (pain score)
- Women with early PPH
- Suspected placental abruption
Trial locations and contacts
No sites are listed yet.
About this study
To compare the efficacy of three different protocols of third stage management in preventing PPH.
Read the detailed description
The third stage of labor refers to the period following the completed delivery of the newborn until the completed delivery of the placenta. The length of the third stage and its complications are affected by the uterine contractility and the duration of placental separation. The normal duration of third stage in nulliparous as well as in multiparous women is less than 30 minutes. There is strong evidence supporting the routine administration of uterotonic agents for the prevention of post-partum hemorrhage (PPH), in order to enhance natural uterine contraction in the third stage of labor, thus reducing the occurrence of PPH by 40%.
There is a joint policy statement between the International Confederation of Midwives (ICM), the International Federation of Gynecology and Obstetrics (FIGO) and the World Health Organization (WHO), all of which recommend active management of the third stage of labor in order to prevent PPH. active management led to a reduction in PPH incidence, maternal Hemoglobin<9g/dL and need for blood transfusion. (4-7).
Active management of the third stage of labor involves prophylactic uterotonic treatment, early cord clamping and controlled cord traction to deliver the placenta. (2) Oxytocin is the first agent of choice for PPH prophylaxis because of its high efficacy and a low incidence of associated side effects. (6-9). Cotter et al found that the use of Oxytocin for PPH prophylaxis in the third stage of labor decreased the rate of maternal blood loss greater than 500 ml by approximately 50%. (10).
Oxytocin route of administration is either intravenously (IV) or intramuscularly (IM), with no significant difference in PPH incidence (9). This is based on a pharmacokinetic research from 1972 which found no difference between the absorption rates in both routes of administration. Since then no further research targeting this question was preformed. (11-12). recent guidelines from WHO, FIGO and ICM all recommended the use of 10 IU Oxytocin IM. (4, 7,13).
Previous studies have investigated the effect of intra-umbilical vein Oxytocin injection in reducing blood loss during the third stage of labor. This route of administration directs treatment to the placental bed and uterine wall, resulting in earlier uterine contraction and placental separation. However, limited published literature is available evaluating the effect of umbilical vein oxytocin injection in routine practices for active management of the third stage of labor. A prospective, randomized controlled trial of 412 women found that intra-umbilical injection of oxytocin alongside active management of the third stage of labor significantly reduced postpartum blood loss and the duration of the third stage (14).
Other uterotonic agents including Syntometrine (IM), Ergometrine (IM or IV) and Misoprostol (IM), can be used in active management of the third stage of labor. However, high quality evidence regarding their efficacy compared to Oxytocin is scarce. (9-10)
- Conditions
- Postpartum Hemorrhage
- Being tested
- Oxytocin, Oxytocin in 100 ml NaCl 0.9%
- 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 Pitocin
The study group: divided into two groups:
- Intramuscular treatment: pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IM Oxytocin during the third stage of labor.
- Combined treatment: pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IM Oxytocin together with 10 IU of IV Oxytocin in 100 ml NaCl 0.9% during the third stage of labor.
Oxytocin in 100 ml NaCl 0.9%Drug
The control group:
pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IV Oxytocin in 100 ml NaCl 0.9% during the third stage of labor. (this is the routine practice in our department).
| Study group | Role | What they receive |
|---|---|---|
| Intramuscular treatment:IV | Experimental | pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IM Oxytocin during the third stage of labor. Receives: Drug: Oxytocin |
| Combined treatment:IV+IM | Experimental | pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IM Oxytocin together with 10 IU of IV Oxytocin in 100 ml NaCl 0.9% during the third stage of labor. Receives: Drug: Oxytocin |
| The control group | Active comparator | pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IV Oxytocin in 100 ml NaCl 0.9% during the third stage of labor. (this is the routine practice in our department). Receives: Drug: Oxytocin in 100 ml NaCl 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin concentration during labor
Measured: first and second day after delivery
Secondary outcomes (1)
Blood count (CBC) on the first and second day after delivery
Measured: first and second day after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startSep 2015
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yariv yogev
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yariv yogev, Rabin Medical Center
- Investigators
- Yariv Yogev, professor, Principal investigator, Director, Division of obstetrics and delivery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319707
- Sponsor's protocol ID
- 0553-14-RMC
- Status last verified
- Sep 2015
- First submitted
- 14 Dec 2014
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Oladapo OT, Okusanya BO, Abalos E, Gallos ID, Papadopoulou A. Intravenous versus intramuscular prophylactic oxytocin for the third stage of labour. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD009332. doi: 10.1002/14651858.CD009332.pub4.
PubMed 33169839
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of the Third Stage of Labor
- ClinicalTrials.gov ID
- NCT02319707
- Acronym / sponsor ID
- 0553-14-RMC
- Conditions
- Postpartum Hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Yariv yogevUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 18 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.
To compare the efficacy of three different protocols of third stage management in preventing PPH.
Detailed description
The third stage of labor refers to the period following the completed delivery of the newborn until the completed delivery of the placenta. The length of the third stage and its complications are affected by the uterine contractility and the duration of placental separation. The normal duration of third stage in nulliparous as well as in multiparous women is less than 30 minutes. There is strong evidence supporting the routine administration of uterotonic agents for the prevention of post-partum hemorrhage (PPH), in order to enhance natural uterine contraction in the third stage of labor, thus reducing the occurrence of PPH by 40%.
There is a joint policy statement between the International Confederation of Midwives (ICM), the International Federation of Gynecology and Obstetrics (FIGO) and the World Health Organization (WHO), all of which recommend active management of the third stage of labor in order to prevent PPH. active management led to a reduction in PPH incidence, maternal Hemoglobin<9g/dL and need for blood transfusion. (4-7).
Active management of the third stage of labor involves prophylactic uterotonic treatment, early cord clamping and controlled cord traction to deliver the placenta. (2) Oxytocin is the first agent of choice for PPH prophylaxis because of its high efficacy and a low incidence of associated side effects. (6-9). Cotter et al found that the use of Oxytocin for PPH prophylaxis in the third stage of labor decreased the rate of maternal blood loss greater than 500 ml by approximately 50%. (10).
Oxytocin route of administration is either intravenously (IV) or intramuscularly (IM), with no significant difference in PPH incidence (9). This is based on a pharmacokinetic research from 1972 which found no difference between the absorption rates in both routes of administration. Since then no further research targeting this question was preformed. (11-12). recent guidelines from WHO, FIGO and ICM all recommended the use of 10 IU Oxytocin IM. (4, 7,13).
Previous studies have investigated the effect of intra-umbilical vein Oxytocin injection in reducing blood loss during the third stage of labor. This route of administration directs treatment to the placental bed and uterine wall, resulting in earlier uterine contraction and placental separation. However, limited published literature is available evaluating the effect of umbilical vein oxytocin injection in routine practices for active management of the third stage of labor. A prospective, randomized controlled trial of 412 women found that intra-umbilical injection of oxytocin alongside active management of the third stage of labor significantly reduced postpartum blood loss and the duration of the third stage (14).
Other uterotonic agents including Syntometrine (IM), Ergometrine (IM or IV) and Misoprostol (IM), can be used in active management of the third stage of labor. However, high quality evidence regarding their efficacy compared to Oxytocin is scarce. (9-10)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intramuscular treatment:IV | Experimental | Drug: Oxytocinpregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IM Oxytocin during the third stage of labor. |
| Combined treatment:IV+IM | Experimental | Drug: Oxytocinpregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IM Oxytocin together with 10 IU of IV Oxytocin in 100 ml NaCl 0.9% during the third stage of labor. |
| The control group | Active comparator | Drug: Oxytocin in 100 ml NaCl 0.9%pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IV Oxytocin in 100 ml NaCl 0.9% during the third stage of labor. (this is the routine practice in our department). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Singleton pregnancy.
- 34-41 weeks of gestation.
- Maternal age between 18 and 45.
Key exclusion criteria (5 listed)
- Women who enter delivery room during the active phase of labor (cervical dilatation greater than 5 cm)
- Coagulation defects
- VAS score>3 (pain score)
- Women with early PPH
- Suspected placental abruption
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: PitocinThe study group: divided into two groups: • Intramuscular treatment: pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IM Oxytocin during the third stage of labor. • Combined treatment: pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IM Oxytocin together with 10 IU of IV Oxytocin in 100 ml NaCl 0.9% during the third stage of labor. | Drug | Combined treatment:IV+IM, Intramuscular treatment:IV |
| Oxytocin in 100 ml NaCl 0.9%The control group: pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IV Oxytocin in 100 ml NaCl 0.9% during the third stage of labor. (this is the routine practice in our department). | Drug | The control group |
Primary outcome
Change in Hemoglobin concentration during labor
Time frame: first and second day after delivery
1 secondary outcome
Blood count (CBC) on the first and second day after delivery
Time frame: first and second day after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
- Derived from this study: PubMed 33169839Oladapo OT, Okusanya BO, Abalos E, Gallos ID, Papadopoulou A. Intravenous versus intramuscular prophylactic oxytocin for the third stage of labour. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD009332. doi: 10.1002/14651858.CD009332.pub4.
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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.
Yariv Yogev, professor principal investigator
Director, Division of obstetrics and delivery
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxytocin and Oxytocin in 100 ml NaCl 0.9% in people with Postpartum Hemorrhage, run by Yariv yogev.
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 3 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: status not confirmed, as of the sponsor's last update on 9 Sep 2015. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yariv Yogev, professor (9723-9377490, yarivy@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin concentration during labor (time frame: first and second day after delivery). 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 NCT02319707, which also lists 1 linked publication.
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 9 Sep 2015.