Preterm Labor Without DeliveryPhase 4NCT03298191
Tocolysis in Prevention of Preterm Labor
A Phase 4 study testing Magnesium Sulfate, Ritodrine and Calcium Channel Blockers in people with Preterm Labor Without Delivery, run by Assiut University at 1 site in Egypt.
Trial summary
Preterm birth is defined as birth before 37 completed weeks of gestation .it occurs in 11.1%of birth globally affecting an estimated 14.9 million babies every year . It is generally accepted that approximately 65%-70%of preterm births are spontaneous,40%-45% of them due to spontaneous preterm labor and… Read more about this study
- Who is it for?
- Ages 17 to 40 years, women only
- Conditions the study is for
- Preterm Labor Without Delivery
- What is being tested?
- Magnesium Sulfate, Ritodrine and Calcium Channel Blockers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Oct 2017to 25 May 2018
- Phase
- Phase 4
- 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 17 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- . Gestational age between 24-37weeks
- Symptoms such as low backache , cramping ,pelvic pressure, excessive vaginal discharge and vaginal spotting .
- Regular uterine contractions at least of 30 seconds duration at a rate of more than 4/30 minutes
- Cervical changes dilatation less than 3cm,effacement lessthan50%.
- Intact membranes.
Who cannot join
- Active vaginal bleeding and placental abruption.
- Chorioamnionitis and intrauterine infection
- Fetal conditions : fetal death or distress, lethal congenital or chromosomal abnormalities and intra uterine growth restriction
- Maternal conditions indicate that pregnancy shouldn't be continued: eclampsia , severe preeclampsia and cardiac diseases
- Drug specific contraindications(contraindication of tocolysis)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mohamed Atef Mohamed
Sohag
mohamed mohamed, +01005537951, mohammedelksoy@yahoo.com
About this study
Official title: Comparative Study on Tocolysis in Prevention of Preterm Labour
Preterm birth is defined as birth before 37 completed weeks of gestation .it occurs in 11.1%of birth globally affecting an estimated 14.9 million babies every year . It is generally accepted that approximately 65%-70%of preterm births are spontaneous,40%-45% of them due to spontaneous preterm labor and 25%-30%following preterm rupture of membranes.preterm birth represents the single largest cause of morbidity and mortality for newborn and is estimated for 29%of deaths in the first four weeks of life and also is estimated for of major cause of morbidity for pregnant women .
Tocolytic agents include a wide range of drugs that can slow or suppress uterine contractions . Tocolytic are considered advantages in spontaneous preterm labor to : (a) allow time for the fetus to mature ,potentially avoiding deleterious effects of pre-maturity . (b)allow time for antenatal corticosteroids to be administered and have clinical effect. (c) allow time for intrauterine transfer to higher-care center where neonatal intensive care facilities are available . the ideal Tocolytic agent should be effective , easy to administer , without significant material ,fetal or neonatal side effects and permit time for antenatal corticosteroids to be administered and take effect . a variety of Tocolytic treatments have been used to inhibit uterine activity in women in spontaneous preterm labor , including betamimetics , calcium channel blockers , magnesium sulfate , prostaglandin inhibitors and oxytocin receptor antagonists however there is considerable global variation in types , doses and regimens of tocolytic agents uses to manage preterm labor .
A comparison study between Ritodrine, magnesium sulfate and Nifedipine in terms of effect and morbidity will be conducted.
- Conditions
- Preterm Labor Without Delivery
- Being tested
- Magnesium Sulfate, Ritodrine, Calcium Channel Blockers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
Those women will be given Magnesium Sulfate for tocolysis
RitodrineDrug
Those women will be given Ritodrine for tocolysis
Calcium Channel BlockersDrug
Those women will be given Calcium Channel Blockers for tocolysis
| Study group | Role | What they receive |
|---|---|---|
| Magnesium sulphate | Experimental | Not described Receives: Drug: Magnesium Sulfate |
| Ritodrine | Experimental | Not described Receives: Drug: Ritodrine |
| Calcium channel blocker | Experimental | Not described Receives: Drug: Calcium Channel Blockers |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time of delivery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start25 Oct 2017 (estimated)
- Primary completion25 Apr 2018 (estimated)
- Study completion25 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm Labor Without DeliveryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- complications ofthe drugs good response to drugs
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed atef mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298191
- Sponsor's protocol ID
- TPL
- Status last verified
- Sep 2017
- First submitted
- 26 Aug 2017
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
PubMed 35947046
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on Tocolysis in Prevention of Preterm Labour
- ClinicalTrials.gov ID
- NCT03298191
- Acronym / sponsor ID
- TPL
- Conditions
- Preterm Labor Without Delivery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Oct 2017 (estimated)
- Primary completion
- 25 Apr 2018 (estimated)
- Study completion
- 25 May 2018 (estimated)
- First posted
- 2 Oct 2017 (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.
Preterm birth is defined as birth before 37 completed weeks of gestation .it occurs in 11.1%of birth globally affecting an estimated 14.9 million babies every year . It is generally accepted that approximately 65%-70%of preterm births are spontaneous,40%-45% of them due to spontaneous preterm labor and 25%-30%following preterm rupture of membranes.preterm birth represents the single largest cause of morbidity and mortality for newborn and is estimated for 29%of deaths in the first four weeks of life and also is estimated for of major cause of morbidity for pregnant women .
Tocolytic agents include a wide range of drugs that can slow or suppress uterine contractions . Tocolytic are considered advantages in spontaneous preterm labor to : (a) allow time for the fetus to mature ,potentially avoiding deleterious effects of pre-maturity . (b)allow time for antenatal corticosteroids to be administered and have clinical effect. (c) allow time for intrauterine transfer to higher-care center where neonatal intensive care facilities are available . the ideal Tocolytic agent should be effective , easy to administer , without significant material ,fetal or neonatal side effects and permit time for antenatal corticosteroids to be administered and take effect . a variety of Tocolytic treatments have been used to inhibit uterine activity in women in spontaneous preterm labor , including betamimetics , calcium channel blockers , magnesium sulfate , prostaglandin inhibitors and oxytocin receptor antagonists however there is considerable global variation in types , doses and regimens of tocolytic agents uses to manage preterm labor .
A comparison study between Ritodrine, magnesium sulfate and Nifedipine in terms of effect and morbidity will be conducted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- complications ofthe drugs good response to drugs
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulphate | Experimental | Drug: Magnesium Sulfate |
| Ritodrine | Experimental | Drug: Ritodrine |
| Calcium channel blocker | Experimental | Drug: Calcium Channel Blockers |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- . Gestational age between 24-37weeks
Key exclusion criteria (5 listed)
- Active vaginal bleeding and placental abruption.
- Chorioamnionitis and intrauterine infection
- Fetal conditions : fetal death or distress, lethal congenital or chromosomal abnormalities and intra uterine growth restriction
- Maternal conditions indicate that pregnancy shouldn't be continued: eclampsia , severe preeclampsia and cardiac diseases
- Drug specific contraindications(contraindication of tocolysis)
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 |
|---|---|---|
| Magnesium SulfateThose women will be given Magnesium Sulfate for tocolysis | Drug | Magnesium sulphate |
| RitodrineThose women will be given Ritodrine for tocolysis | Drug | Ritodrine |
| Calcium Channel BlockersThose women will be given Calcium Channel Blockers for tocolysis | Drug | Calcium channel blocker |
Primary outcome
The time of delivery
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Derived from this study: PubMed 35947046Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
- Individual participant dataSharing planned: No
Related trials for Preterm Labor Without Delivery
Recruiting
Evaluation of a New Predictive Test of Preterm Birth in Case of Threatened Preterm Labor
Threatened Preterm Labor, Preterm Delivery
RecruitingPhase 1
Pharmacokinetics and Placental Transfer of Caffeine
Preterm Labor With Preterm Delivery, Premature Birth
Recruiting
Synbiotics in Patients at RIsk fOr Preterm Birth
Preterm Spontaneous Labor With Preterm Delivery, Preterm Birth
Recruiting
Comparing Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor
Preterm Labor With Preterm Delivery, Premature Rupture of Membranes Prolonged
Active, not recruitingObservational study
MIRACLE of LIFE Study
Preterm Labor, Preterm Birth
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium Sulfate, Ritodrine and Calcium Channel Blockers in people with Preterm Labor Without Delivery, run by Assiut University at 1 site in Egypt.
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 5 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: status not confirmed, as of the sponsor's last update on 2 Oct 2017. 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time of delivery (time frame: 6 months). 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 NCT03298191, which also lists 1 linked publication.
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 2 Oct 2017; AzTrials last refreshed its copy on 31 Oct 2026.