Managing Preterm Labor Clinical Trial
Official title:
Transdermal Nitroglycerin and Nifedipine for Managing Preterm Labor: a Randomized Clinical Trial
| Verified date | October 2015 |
| Source | Shiraz University of Medical Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
One of the important complications of pregnancy is preterm labor (PTL) and delivery. There are different tocolytic agents to enhance the time of delivery. The aim of this study was to compare the effect of transdermal nitroglycerin (glyceryl trinitrate, GTN) and oral nifedipine for managing preterm labor. This was a randomized clinical trial in women admitted with diagnosis of PTL. Group one have received transdermal GTN whereas group two have received oral nifedipine, vital signs, FHR, contractions, dilation and effacement as well as gestation age at the time of delivery have been monitored and evaluated in both groups of patient. Our main goal has been delay of delivery to have the most beneficial effect of primary corticosteroid administration for fetus.
| Status | Completed |
| Enrollment | 112 |
| Est. completion date | October 2014 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 40 Years |
| Eligibility |
Inclusion Criteria: - GA between 24 to 34 weeks - early-onset signs of delivery (=4 uterine contractions during 20 minutes, =1 centimeters (cm) of dilation and effacement over 80%). Exclusion Criteria: - maternal or fetal life-threatening conditions which require emergency termination - multiple pregnancy - premature rupture of membrane - fatal anomaly or intra-uterine fetal death - cervical dilation =4 cm - any tocolytic treatment in previous days and positive allergy to GTN |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Shiraz University of Medical Sciences |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time of Delivery | Delivery | ||
| Secondary | APGAR scores | The Apgar scale is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are summarized using words chosen to form a backronym (Appearance, Pulse, Grimace, Activity, Respiration). The Apgar scale is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are summarized using words chosen to form a backronym (Appearance, Pulse, Grimace, Activity, Respiration). |
Delivery |