PreeclampsiaNCT01360060
Analgesia After Cesarean Section
An observational study of Preeclampsia and Pregnancy, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Magnesium sulphate is the first line therapy for the management of preeclampsia and eclampsia in obstetrics. Perioperative administration of magnesium sulphate has been proved to be an effective as an analgesic adjuvant. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Preeclampsia, Pregnancy
- What is being tested?
- Magnesium Sulphate
- How many people
- 503 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2010to Mar 2011
- 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: medical record review
Who may be able to join
- parturients undergoing Cesarean section
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul national university bundang hospital
Seongnam-si, Gyeonggi-do
About this study
Magnesium sulphate is the first line therapy for the management of preeclampsia and eclampsia in obstetrics. Perioperative administration of magnesium sulphate has been proved to be an effective as an analgesic adjuvant. The investigators evaluated the analgesic effect of magnesium in parturients undergoing Cesarean section.
- Conditions
- Preeclampsia, Pregnancy
- Being tested
- Magnesium Sulphate
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulphateDrug
Magnesium sulphate was infused for the management of preeclampsia at perioperative period.
| Study group | Role | What they receive |
|---|---|---|
| Group N | parturients who had undergone Cesarean section under the diagnosis of non-preeclampsia | |
| Group P | parturients who had undergone Cesarean section under the diagnosis of preeclampsia Receives: Drug: Magnesium Sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of numeric rating scale (NRS) of postoperative pain during postoperative period
Measured: postoperative 1, 2, 3, and 4 day
Secondary outcomes (2)
incidence of stopping of intravenous PCA during postoperative 4 days
Measured: during postoperative 4 days
serum magnesium level of group P
Measured: preoperative 1 h and postoperative 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startDec 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360060
- Sponsor's protocol ID
- Mg_section
- Status last verified
- May 2011
- First submitted
- 17 May 2011
- Last updated
- 25 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia After Cesarean Section
- ClinicalTrials.gov ID
- NCT01360060
- Acronym / sponsor ID
- Mg_section
- Conditions
- Preeclampsia, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 25 May 2011 (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.
Magnesium sulphate is the first line therapy for the management of preeclampsia and eclampsia in obstetrics. Perioperative administration of magnesium sulphate has been proved to be an effective as an analgesic adjuvant. The investigators evaluated the analgesic effect of magnesium in parturients undergoing Cesarean section.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group N | – | –parturients who had undergone Cesarean section under the diagnosis of non-preeclampsia |
| Group P | – | Drug: Magnesium Sulphateparturients who had undergone Cesarean section under the diagnosis of preeclampsia |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- medical record review
Key inclusion criteria (1 listed)
- parturients undergoing Cesarean section
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Magnesium SulphateMagnesium sulphate was infused for the management of preeclampsia at perioperative period. | Drug | Group P |
Primary outcome
Change of numeric rating scale (NRS) of postoperative pain during postoperative period
Time frame: postoperative 1, 2, 3, and 4 day
2 secondary outcomes
incidence of stopping of intravenous PCA during postoperative 4 days
Time frame: during postoperative 4 days
serum magnesium level of group P
Time frame: preoperative 1 h and postoperative 1 day
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 25 May 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Preeclampsia and Pregnancy, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 1 inclusion and 0 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 25 May 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 South Korea. 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?
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?
Change of numeric rating scale (NRS) of postoperative pain during postoperative period (time frame: postoperative 1, 2, 3, and 4 day). 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 25 May 2011.