Nonreassuring Fetal StatusNCT05326269
Acute Tocolysis With Terbutaline for Suspected Fetal Distress
A study testing Terbutaline in people with Nonreassuring Fetal Status, run by Hospital Kemaman at 1 site in Malaysia.
Trial summary
The trial was to determine the effect of administrating subcutaneous terbutaline prior to emergency caesarean delivery for suspected fetal distress Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nonreassuring Fetal Status
- What is being tested?
- Terbutaline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteMalaysia
- Study dates
- 23 Apr 2017to 15 Sep 2019
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- maternal cardiopathy
- hyperthyroidism
- abruptio placentae or other placental accidents
- hypertensive disease of pregnancy
- hyperstimulation with oxytocin
- multiple gestation
Show all 9Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Tocolysis With Terbutaline vs Placebo Prior to Emergency Caesarean Delivery for Suspected Intrauterine Fetal Compromise
The trial was to determine the effect of administrating subcutaneous terbutaline prior to emergency caesarean delivery for suspected fetal distress
Read the detailed description
The trial was a double-blinded, placebo-controlled study using subcutaneous terbutaline for acute tocolysis prior to emergency caesarean delivery in suspected fetal distress. The intervention (subcutaneous terbutaline) was compared to placebo looking at the neonatal and maternal outcomes.
The primary outcome was the proportion of babies with neonatal acidosis (based on umbilical artery blood sampling at delivery). Other outcome of interest were the mean cord pH and base excess, the Apgar score at 5 minutes after delivery, he proportion of babies requiring intubation and admission to the Neonatal Intensive Care Unit. The maternal outcomes of interest were the changes in mean arterial pressure (before and after the drug or placebo injection), the maternal heart rate changes, the estimated blood loss, and the hematocrit changes.
- Conditions
- Nonreassuring Fetal Status
- Being tested
- Terbutaline
- Keywords
- fetal resuscitation, acute tocolysis, fetal distress, cesarean section
- Medical subject headings
- Fetal Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerbutalineDrug
Also called beta mimetic
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Terbutaline 0.5 mls (0.25 mg) , subcutaneously Receives: Drug: Terbutaline |
| Control group | Placebo comparator | Placebo (normal saline) 0.5 mls , subcutaneously Receives: Drug: Terbutaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal acidosis
Umbilical artery acidosis
Measured: within 1 hour of delivery
Secondary outcomes (7)
Neonatal acid base status
Mean umbilical artery pH \& base excess
Measured: within 1 hour of delivery
Neonatal Apgar score
Mean Apgar score at 5 minutes of life
Measured: 5 minutes after delivery
Neonatal intensive care unit admission
Number of babies admitted to neonatal intensive care unit
Measured: Within 24 hours of delivery
Maternal blood pressure
Mean maternal arterial pressure (before and after drug or placebo administration)
Measured: Within 1 hours after drug administration
Maternal heart rate
Mean maternal heart rate changes (before and after drug or placebo administration)
Measured: Within 1 hours after drug administration
Blood loss
Mean estimated blood loss
Measured: Within 24 hours of delivery
Hematocrit change
Mean hematocrit changes before and after cesarean section
Measured: Within 24 hours of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start23 Apr 2017
- Primary completion15 Sep 2019
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nonreassuring Fetal StatusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Kemaman
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahar Azuar Zakaria, Hospital Kemaman
- Investigators
- Zahar A Zakaria, MD, Principal investigator, Hospital Kemaman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326269
- Sponsor's protocol ID
- NMRR-16-1985-331
- Status last verified
- Apr 2022
- First submitted
- 22 Mar 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon request
Publications
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. doi: 10.1016/s0002-9378(87)80178-3.
PubMed 3303936Ingemarsson 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. doi: 10.1016/0002-9378(85)90690-8.
PubMed 4073156Leathersich SJ, Vogel JP, Tran TS, Hofmeyr GJ. Acute tocolysis for uterine tachysystole or suspected fetal distress. Cochrane Database Syst Rev. 2018 Jul 4;7(7):CD009770. doi: 10.1002/14651858.CD009770.pub2.
PubMed 29971813Pullen 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. doi: 10.1016/j.ajog.2007.06.063.
PubMed 17904983Buckley 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.
PubMed 32378185Magann 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. doi: 10.1111/j.1479-828x.1993.tb02109.x.
PubMed 8179541
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Tocolysis With Terbutaline vs Placebo Prior to Emergency Caesarean Delivery for Suspected Intrauterine Fetal Compromise
- ClinicalTrials.gov ID
- NCT05326269
- Acronym / sponsor ID
- NMRR-16-1985-331
- Conditions
- Nonreassuring Fetal Status
- Keywords
- fetal resuscitation, acute tocolysis, fetal distress, cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospital KemamanUniversity, hospital or other
- Study start
- 23 Apr 2017 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 13 Apr 2022 (actual)
- 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.
The trial was to determine the effect of administrating subcutaneous terbutaline prior to emergency caesarean delivery for suspected fetal distress
Detailed description
The trial was a double-blinded, placebo-controlled study using subcutaneous terbutaline for acute tocolysis prior to emergency caesarean delivery in suspected fetal distress. The intervention (subcutaneous terbutaline) was compared to placebo looking at the neonatal and maternal outcomes.
The primary outcome was the proportion of babies with neonatal acidosis (based on umbilical artery blood sampling at delivery). Other outcome of interest were the mean cord pH and base excess, the Apgar score at 5 minutes after delivery, he proportion of babies requiring intubation and admission to the Neonatal Intensive Care Unit. The maternal outcomes of interest were the changes in mean arterial pressure (before and after the drug or placebo injection), the maternal heart rate changes, the estimated blood loss, and the hematocrit changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Drug: TerbutalineTerbutaline 0.5 mls (0.25 mg) , subcutaneously |
| Control group | Placebo comparator | Drug: TerbutalinePlacebo (normal saline) 0.5 mls , subcutaneously |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- maternal cardiopathy
- hyperthyroidism
- abruptio placentae or other placental accidents
- hypertensive disease of pregnancy
- hyperstimulation with oxytocin
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 |
|---|---|---|
| TerbutalineAlso: beta mimeticSubcutaneous injection | Drug | Control group, Intervention group |
Primary outcome
Neonatal acidosis
Time frame: within 1 hour of delivery
Umbilical artery acidosis
7 secondary outcomes
Neonatal acid base status
Time frame: within 1 hour of delivery
Neonatal Apgar score
Time frame: 5 minutes after delivery
Neonatal intensive care unit admission
Time frame: Within 24 hours of delivery
Maternal blood pressure
Time frame: Within 1 hours after drug administration
Maternal heart rate
Time frame: Within 1 hours after drug administration
Blood loss
Time frame: Within 24 hours of delivery
Hematocrit change
Time frame: Within 24 hours of delivery
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 13 Apr 2022.
- Background: PubMed 3303936Patriarco 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. doi: 10.1016/s0002-9378(87)80178-3.
- Background: PubMed 4073156Ingemarsson 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. doi: 10.1016/0002-9378(85)90690-8.
- Background: PubMed 29971813Leathersich SJ, Vogel JP, Tran TS, Hofmeyr GJ. Acute tocolysis for uterine tachysystole or suspected fetal distress. Cochrane Database Syst Rev. 2018 Jul 4;7(7):CD009770. doi: 10.1002/14651858.CD009770.pub2.
- Background: PubMed 17904983Pullen 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. doi: 10.1016/j.ajog.2007.06.063.
- Results publication: PubMed 32378185Buckley 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.
- Results publication: PubMed 8179541Magann 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. doi: 10.1111/j.1479-828x.1993.tb02109.x.
- Individual participant dataSharing planned: No. Upon request
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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.
Zahar A Zakaria, MD principal investigator
Hospital Kemaman
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Terbutaline in people with Nonreassuring Fetal Status, run by Hospital Kemaman at 1 site in Malaysia.
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 5 inclusion and 9 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 13 Apr 2022. 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 Malaysia. 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. Some participants in this study may receive a placebo. 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?
Neonatal acidosis (time frame: within 1 hour of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05326269, which also lists 6 linked publications.
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 13 Apr 2022.