Nonreassuring Fetal Status Clinical Trial
Official title:
Acute Tocolysis With Terbutaline vs Placebo Prior to Emergency Caesarean Delivery for Suspected Intrauterine Fetal Compromise
Verified date | April 2022 |
Source | Hospital Kemaman |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The trial was to determine the effect of administrating subcutaneous terbutaline prior to emergency caesarean delivery for suspected fetal distress
Status | Completed |
Enrollment | 100 |
Est. completion date | September 15, 2019 |
Est. primary completion date | September 15, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - term singleton pregnancy - cephalic presentation - in labour with cervix dilatation > 4cm and regular uterine contractions of 3 or more 10 min - abnormal fetal heart rate status diagnosed using standard electronic FHR according to NICE guideline (2014) - acceptance of participation by the signing of a written consent. Exclusion Criteria - maternal cardiopathy - hyperthyroidism - abruptio placentae or other placental accidents - hypertensive disease of pregnancy - hyperstimulation with oxytocin - multiple gestation - abnormal fetus planned for conservative management - evidence of intrauterine growth restriction - patient on medication which will interact with terbutaline (tricyclic antidepressants, beta-blockers, diuretics and sympathomimetic medicine). |
Country | Name | City | State |
---|---|---|---|
Malaysia | Hospital Kemaman | Kuala Terengganu | Terengganu |
Lead Sponsor | Collaborator |
---|---|
Hospital Kemaman |
Malaysia,
Buckley VA, Wu J, De Vries B. Outcomes following acute tocolysis prior to emergency caesarean section. Aust N Z J Obstet Gynaecol. 2020 Dec;60(6):884-889. doi: 10.1111/ajo.13170. Epub 2020 May 6. — View Citation
Ingemarsson I, Arulkumaran S, Ratnam SS. Single injection of terbutaline in term labor. I. Effect on fetal pH in cases with prolonged bradycardia. Am J Obstet Gynecol. 1985 Dec 15;153(8):859-65. — View Citation
Leathersich SJ, Vogel JP, Tran TS, Hofmeyr GJ. Acute tocolysis for uterine tachysystole or suspected fetal distress. Cochrane Database Syst Rev. 2018 Jul 4;7:CD009770. doi: 10.1002/14651858.CD009770.pub2. Review. — View Citation
Magann EF, Cleveland RS, Dockery JR, Chauhan SP, Martin JN Jr, Morrison JC. Acute tocolysis for fetal distress: terbutaline versus magnesium sulphate. Aust N Z J Obstet Gynaecol. 1993 Nov;33(4):362-4. — View Citation
Patriarco MS, Viechnicki BM, Hutchinson TA, Klasko SK, Yeh SY. A study on intrauterine fetal resuscitation with terbutaline. Am J Obstet Gynecol. 1987 Aug;157(2):384-7. — View Citation
Pullen KM, Riley ET, Waller SA, Taylor L, Caughey AB, Druzin ML, El-Sayed YY. Randomized comparison of intravenous terbutaline vs nitroglycerin for acute intrapartum fetal resuscitation. Am J Obstet Gynecol. 2007 Oct;197(4):414.e1-6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neonatal acidosis | Umbilical artery acidosis | within 1 hour of delivery | |
Secondary | Neonatal acid base status | Mean umbilical artery pH & base excess | within 1 hour of delivery | |
Secondary | Neonatal Apgar score | Mean Apgar score at 5 minutes of life | 5 minutes after delivery | |
Secondary | Neonatal intensive care unit admission | Number of babies admitted to neonatal intensive care unit | Within 24 hours of delivery | |
Secondary | Maternal blood pressure | Mean maternal arterial pressure (before and after drug or placebo administration) | Within 1 hours after drug administration | |
Secondary | Maternal heart rate | Mean maternal heart rate changes (before and after drug or placebo administration) | Within 1 hours after drug administration | |
Secondary | Blood loss | Mean estimated blood loss | Within 24 hours of delivery | |
Secondary | Hematocrit change | Mean hematocrit changes before and after cesarean section | Within 24 hours of delivery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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N/A |