Clinical Trial: Intravenous Nitroglycerin for Retained Placenta Extraction: a Multicenter Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Intravenous Nitroglycerin for Retained Placenta Extraction: a Multicenter Study

Brief 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.

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 Summary:

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.

Same as current

Current Secondary Outcome:

  • hypotension [ Time Frame: 20 mintues ]
  • headache [ Time Frame: 2 hour ]
  • blood loss [ Time Frame: 24 hour ]


Original Secondary Outcome: Same as current

Information By: Mahidol University

Dates:
Date Received: June 28, 2008
Date Started: February 2008
Date Completion:
Last Updated: March 6, 2011
Last Verified: June 2008