Effect of Maternal and Neonatal Oxygenation
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Intraoperative supplemental oxygen has been given for most parturients undergoing cesarean section under spinal anesthesia. However, evidences supporting the practice is not clear nowadays, especially for healthy parturients who are monitored continuously with pulse oximeter. Furthermore, hyperoxia may produce free radicles which could harm fetus and newborns.
Changing practice is not that easy. This study has been conducted to prove that supplemental oxygen is not necessary for healthy parturients during cesarean section.
| Condition | Intervention | Phase |
|---|---|---|
|
Peer Review, Research |
Drug: oxygen Drug: room air |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of Neonate and Maternal Oxygenation in Low-dose Oxygen Supplement by Oxygen Cannula or Non- Supplement in Elective Cesarean Section: a Randomized Controlled Trial |
- proportion of maternal desaturation [ Time Frame: intraoperative period ] [ Designated as safety issue: Yes ]Oxygen saturation < 94% once.
- neonatal outcomes [ Time Frame: intraoperative period ] [ Designated as safety issue: Yes ]Apgar score and parameters from umbilical cord gas
| Estimated Enrollment: | 340 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: room air
no supplemental oxygen in intraoperative period
|
Drug: room air
parturients will not receive supplemental oxygen.
Other Name: room air
|
|
Experimental: canula
supplemental oxygen with oxygen canula 3LPM in intraoperative period.
|
Drug: oxygen
supplemental oxygen 3LPM in intraoperative period
Other Name: oxygen canula
|
Detailed Description:
Supplemental oxygen has been routinely given to parturients because doctors were concerned about desaturation. However, the evidences for giving oxygen was not strong, and the condition nowadays can be detected immediately with pulse oximeter which is a standard monitoring.
After this study finished, we will set a safety guideline for supplemental oxygen for healthy parturients undergoing elective cesarean section.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Aged > 18 years old.
- Term pregnancy (gestational age 37 -42 weeks).
- Singleton
- Elective cesarean section.
Exclusion Criteria:
- History of infertility
- Diabetes
- Hypertension or preeclampsia
- Heart disease
- Morbid obesity
- Premature rupture of membrane
- Placenta previa
- Preoperative oxygen saturation < 95%
Contacts and Locations| Contact: Aungsumat Wangdee, RN | aungsumat@hotmail.com |
| Thailand | |
| Siriraj hospital | Not yet recruiting |
| Bangkok, Thailand, 10700 | |
| Contact 662-4197990 | |
| Principal Investigator: Arunotai Siriussawakul, MD. | |
| Principal Investigator: | Arunotai Siriussawakul, MD. | Mahidol University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Mahidol University |
| ClinicalTrials.gov Identifier: | NCT01530971 History of Changes |
| Other Study ID Numbers: | 10AS00008/044/10 |
| Study First Received: | February 8, 2012 |
| Last Updated: | February 11, 2012 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by Mahidol University:
|
oxygen pregnancy caesarean section anesthetic techniques |
ClinicalTrials.gov processed this record on May 23, 2013