Retained PlacentaPhase 4NCT00707928
Intravenous Nitroglycerin for Retained Placenta Extraction: a Multicenter Study
A Phase 4 study testing nitroglycerine and NSS in people with Retained Placenta, run by Mahidol University at 1 site in Thailand.
Trial summary
Primary objective The primary objective of this study is to see whether intravenous (IV) NTG 100-200 microgram can effectively help extract retained placenta as compared to placebo, in a randomized controlled multicenter study. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Retained Placenta
- What is being tested?
- nitroglycerine and NSS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2008to Dec 2010
- Phase
- Phase 4
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy pregnant patient (ASA classification I ,II )
- Normal pregnancy with at least 28 week gestation
Who cannot join
- ASA classification III and up
- Having complication of pregnancy such as hypertensive disease of pregnancy,
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital
Bangkok, 10700
About this study
Primary objective The primary objective of this study is to see whether intravenous (IV) NTG 100-200 microgram can effectively help extract retained placenta as compared to placebo, in a randomized controlled multicenter study.
Secondary objective is to compare the hypotensive effects of NTG as compared to placebo, including others side effects such as headache, blood loss, or others.
Read the detailed description
After the approval of the Ethical committee of each institute, and consent signed by the patient, 100 patients with retained placenta were divided into 2 groups in 5 tertiary care centers, university hospitals. By using the program research randomizer (from www. Randomizer.org/form.htm), with the block of 10 and the numbers within the concealed envelopes, totally 100 patients with retained placenta will be divided into 2 groups to have either 100-200 microgram of IV, NTG or IV placebo. Due to unequal number of the cases enrolled in each centers, they will receive 10 envelopes for 10 cases (5 NTG and 5 placebo) at a time. When they finish the first 10 cases, they will start another 10 cases of the next set until all 10 sets has been started. Each of 5 centers might enroll the cases between 10 to 40 cases up to their populations..
Once a diagnosis of retained placenta has been made ( ≥ 30 min after delivery), Hematocrit will be checked and IV crystalloid solution 500 ml has been rapidly perfuse and noninvasive monitored included pulse oximetry, electrocardiogram and noninvasive blood pressure will be monitored.
Patients with signs of hypovolemia ( SBP < 100 mmHg, or pulse > 100/min), or ASA classification > II will be excluded from the study.
First step: In the treatment group, 100 microgram of NTG will be given and wait for 80 seconds ( maximum relaxation effects of IV NTG)(5,6) before starting gently cord traction (1min). If the placenta can not be extracted, another 100 microgram NTG from the same syringe will be given and wait for another 80 seconds before starting another extraction (1min), If the placenta can not be extracted, it will be considered failed. In the placebo group, NSS will be used instead of NTG.
Second step: To give a chance for patients in placebo group, another syringe with 200 microgram will be given as in the first step for the placebo group. In the treatment group, NSS will be used instead of NTG. The outcome in the second step will not be included in the first step.( The solutions in both syringes which will be prepared by the research assistant who will not involve in the study, will be blinded to the patient, the obstetrician, the anesthesiologist and the investigator) General anesthesia will be used for manual removal of placenta in cases that placenta can not be extracted after the second step.
Once the placenta had been delivered, oxytocin or ergometrine will be administered. Fentanyl 50-100 microgram can be given if the cord traction is considered painful.
Vital signs will be recorded before the first NTG bolus and thereafter at 1 min interval for 5 min then every 2 min for 10 min then every 5 min. for 20 min(see the CRF).
The patient will be followed up closely for 24 h postoperatively and Hct will be checked , including the final results upon discharge home.
- Conditions
- Retained Placenta
- Being tested
- nitroglycerine, NSS
- Keywords
- retained placenta
- Medical subject headings
- Placenta, Retained
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nitroglycerineDrug
Also called trinitroglycerin,trinitroglycerine,glyceryl trinitrate
nitroglycerine 100 microgram intravenous.Once the placenta had been delivered, oxytocin or ergometrine will be administered. Fentanyl 50-100 microgram can be given if the cord traction is considered painful.
NSSOther
Also called normal saline
NSS.Once the placenta had been delivered, oxytocin or ergometrine will be administered. Fentanyl 50-100 microgram can be given if the cord traction is considered painful.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 1=nitroglycerine 100 microgram intravenous100-200 microgram of IV. Receives: Drug: nitroglycerine |
| 2 | Placebo comparator | 2=placebo with the same volume as NTG 100-200 microgram of IV. Receives: Other: NSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful of placenta extraction
Measured: 5 mintues
Secondary outcomes (3)
hypotension
Measured: 20 mintues
headache
Measured: 2 hour
blood loss
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retained PlacentaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Investigators
- Shusee Visalyaputra, MD, Principal investigator, Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok 10700
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707928
- Sponsor's protocol ID
- Si249/2007
- Status last verified
- Jun 2008
- First submitted
- 28 Jun 2008
- Last updated
- 8 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Nitroglycerin for Retained Placenta Extraction: a Multicenter Study
- ClinicalTrials.gov ID
- NCT00707928
- Acronym / sponsor ID
- Si249/2007
- Conditions
- Retained Placenta
- Keywords
- retained placenta
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 1 Jul 2008 (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.
Primary objective The primary objective of this study is to see whether intravenous (IV) NTG 100-200 microgram can effectively help extract retained placenta as compared to placebo, in a randomized controlled multicenter study.
Secondary objective is to compare the hypotensive effects of NTG as compared to placebo, including others side effects such as headache, blood loss, or others.
Detailed description
After the approval of the Ethical committee of each institute, and consent signed by the patient, 100 patients with retained placenta were divided into 2 groups in 5 tertiary care centers, university hospitals. By using the program research randomizer (from www. Randomizer.org/form.htm), with the block of 10 and the numbers within the concealed envelopes, totally 100 patients with retained placenta will be divided into 2 groups to have either 100-200 microgram of IV, NTG or IV placebo. Due to unequal number of the cases enrolled in each centers, they will receive 10 envelopes for 10 cases (5 NTG and 5 placebo) at a time. When they finish the first 10 cases, they will start another 10 cases of the next set until all 10 sets has been started. Each of 5 centers might enroll the cases between 10 to 40 cases up to their populations..
Once a diagnosis of retained placenta has been made ( ≥ 30 min after delivery), Hematocrit will be checked and IV crystalloid solution 500 ml has been rapidly perfuse and noninvasive monitored included pulse oximetry, electrocardiogram and noninvasive blood pressure will be monitored.
Patients with signs of hypovolemia ( SBP < 100 mmHg, or pulse > 100/min), or ASA classification > II will be excluded from the study.
First step: In the treatment group, 100 microgram of NTG will be given and wait for 80 seconds ( maximum relaxation effects of IV NTG)(5,6) before starting gently cord traction (1min). If the placenta can not be extracted, another 100 microgram NTG from the same syringe will be given and wait for another 80 seconds before starting another extraction (1min), If the placenta can not be extracted, it will be considered failed. In the placebo group, NSS will be used instead of NTG.
Second step: To give a chance for patients in placebo group, another syringe with 200 microgram will be given as in the first step for the placebo group. In the treatment group, NSS will be used instead of NTG. The outcome in the second step will not be included in the first step.( The solutions in both syringes which will be prepared by the research assistant who will not involve in the study, will be blinded to the patient, the obstetrician, the anesthesiologist and the investigator) General anesthesia will be used for manual removal of placenta in cases that placenta can not be extracted after the second step.
Once the placenta had been delivered, oxytocin or ergometrine will be administered. Fentanyl 50-100 microgram can be given if the cord traction is considered painful.
Vital signs will be recorded before the first NTG bolus and thereafter at 1 min interval for 5 min then every 2 min for 10 min then every 5 min. for 20 min(see the CRF).
The patient will be followed up closely for 24 h postoperatively and Hct will be checked , including the final results upon discharge home.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: nitroglycerine1=nitroglycerine 100 microgram intravenous100-200 microgram of IV. |
| 2 | Placebo comparator | Other: NSS2=placebo with the same volume as NTG 100-200 microgram of IV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy pregnant patient (ASA classification I ,II )
- Normal pregnancy with at least 28 week gestation
Key exclusion criteria (2 listed)
- ASA classification III and up
- Having complication of pregnancy such as hypertensive disease of pregnancy,
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 |
|---|---|---|
| nitroglycerineAlso: trinitroglycerin,trinitroglycerine,glyceryl trinitratenitroglycerine 100 microgram intravenous.Once the placenta had been delivered, oxytocin or ergometrine will be administered. Fentanyl 50-100 microgram can be given if the cord traction is considered painful. | Drug | 1 |
| NSSAlso: normal salineNSS.Once the placenta had been delivered, oxytocin or ergometrine will be administered. Fentanyl 50-100 microgram can be given if the cord traction is considered painful. | Other | 2 |
Primary outcome
successful of placenta extraction
Time frame: 5 mintues
3 secondary outcomes
hypotension
Time frame: 20 mintues
headache
Time frame: 2 hour
blood loss
Time frame: 24 hour
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 8 Mar 2011.
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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.
Shusee Visalyaputra, MD principal investigator
Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok 10700
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nitroglycerine and NSS in people with Retained Placenta, run by Mahidol University at 1 site in Thailand.
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 2 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 8 Mar 2011. 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 Thailand. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
successful of placenta extraction (time frame: 5 mintues). 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 8 Mar 2011; AzTrials last refreshed its copy on 28 Oct 2026.