Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: www.pactr.org
Trial no.: PACTR202004681537890 Date of Approval: 16/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Prevention of premature birth by Nifedipine alone or with Indomethacin
Official scientific title A comparative study on the efficacy of nifedipine/Indomethacin combination and nifedipine monotherapy for prevention of preterm birth in Sudanese pregnant women
Brief summary describing the background and objectives of the trial This trial is to participate with the efforts aiming to provide safe preventive therapy for preterm labour to avoid it's associated unfortunate events. This is a single hospital randomized controlled study. Women, aged ≥18 years, who diagnosed as threatened preterm labour patient and their gestational age is between 25 and 34 weeks are eligible for this trial participation. The diagnosis of threatened preterm labour is defined by uterine contractions, at least 3 contractions per 30 minutes, and one of the following: 1- a cervical length of ≤10 mm or 2) a cervical length of 11-30 mm 3- ruptured amniotic membranes. Patients with singleton or twin pregnancies are eligible, independent of the position of the fetus. will be randomly allocated to treatment with nifedipine/Indomethacin combination or nifedipine monotherapy. Primary outcomes are to compare the efficacy and safety profile of the tocolytic agents. The secondary outcome is estimate associated neonatal morbidity and mortality.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 20/06/2020
Actual trial start date
Anticipated date of last follow up 20/06/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 346
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Research Ethical Committee of the Department of Obstetric and Gynaecology, Faculty of Medicine, University of Gezira, Sudan
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group nifedipine monotherapy the patient will receive 20 mg oral nifedipine combined with a rectal placebo. If contractions inhibition occurs for two hours, the patient will continue receiving 20 mg of oral nifedipine four hours for 48 h, the maximum dose should not exceed 180 mg per day. Rectal placebo will be repeated after 90 min of the first dosage and then it will be prescribed every 4 h 48 hours the patient will receive 20 mg oral nifedipine combined with a rectal placebo. If contractions inhibition occurs for two hours, the patient will continue receiving 20 mg of oral nifedipine four hours for 48 h, the maximum dose should not exceed 180 mg per day. Rectal placebo will be repeated after 90 min of the first dosage and then it will be prescribed every 4 h 173 Active-Treatment of Control Group
Experimental Group Indomethacin and Nifedipine combination therapy Nifedipine dosage is 20 mg may followed by 20 mg every 4 hours Indomethacin dosage is 100 mg rectal suppositories may followed by oral 25 my every 4 hours 48 hours The patient will administer a combination of oral nifedipine and rectal indomethacin. For nifedipine, The patient will receive 20 mg oral nifedipine. The combination also includes also 100 mg of rectal indomethacin. In the case of inhibiting contractions after two hours, the patient will receive 25 mg of oral indomethacin and 20 mg of oral nifedipine every four hours for 24 hours. The maximum daily dosage will not exceed 200 mg/day for indomethacin and 180 mg per day for nifedipine with a maximum duration of 48 hours. Antenatal corticosteroids will be provided according to the guidelines 173
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women, aged ≥18 years, who diagnosed as threatened preterm labor patient And their gestational age is between 25 and 34 weeks are eligible for this trial participation. The diagnosis of threatened preterm labor is defined by uterine contractions, at least 3 contractions per 30 minutes, and one of the following: 1- a cervical length of ≤10 mm or 2) a cervical length of 11-30 mm 3- ruptured amniotic membranes. Patients with singleton or twin pregnancies are eligible, Any fetus position will be included. Any condition considered as contra-indication for tocolysis (i.e hypertension or use of anti-hypertensive medication, signs of fetal distress or intrauterine infection, severe vaginal bleeding, myocardial infarction (less than1 month), unstable angina pectoris), more than 5 cm cervical dilatation, cerclage, suspicion in neonatal chromosomal or structural anomalies and tocolytic treatment for more than 6 hours prior to arrival in a participating hospital. Adult: 19 Year-44 Year 18 Year(s) 48 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/03/2020 Research Ethical Committee of the Department of Obstetrics and Gynaecology. Faculty of Medicine. University of Gezira. Sudan.
Ethics Committee Address
Street address City Postal code Country
Wad Medani Hospital Road Wad Madani 00249 Sudan
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome will be an estimation of the tocolytic efficacy and safety profile of the tocolytic therapies Indomethacin/Nifedipine combination versus Nifedipine monotherapy on delivering mother, which will be assessed in terms of the proportion of women who will not deliver and who will not need an alternate tocolytic medication within 48 hours after the first administration of the study drug. Safety assessment will be by assessing maternal associated adverse effects that included maternal tachycardia (i.e. heart rate above 120 beats per minute), hypotension (i.e. systolic blood pressure less than 90 mm Hg), other symptoms like palpitations, headache, nausea, vomiting, itching, and rash. 48 hours
Secondary Outcome To estimate associated neonatal morbidity and mortality may associate with the tocolytic therapies Indomethacin/Nifedipine combination versus Nifedipine monotherapy which includes gestational age at delivery and neonatal morbidity and mortality related to prematurity (lung diseases, severe intraventricular hemorrhage, periventricular leukomalacia, sepsis, necrotizing enterocolitis), gestational age at delivery. That will be assessed until discharge from the hospital or neonatal death. Until discharge from the hospital or neonatal death. could reach 1 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Wad Medani Teaching Hospital Wad Medani Hospital Road Wad Madani 00249 Sudan
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohammed Haider Hassan Ibrahim Medani Hospital Road Medani 00249 Sudan
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohammed Haider Hassan Ibrahim Wad Madeni Hospital Road Wad Madeni 00249 Sudan Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammed Ibrahim m_haider8430@hotmail.com 00249999880325 Awooda Road
City Postal code Country Position/Affiliation
Wad Madani 00249 Sudan Assistant professor of clinical pharmacology
Role Name Email Phone Street address
Scientific Enquiries Ishag Adam ishagadam@hotmail.com 00966537644287 Nuzha street
City Postal code Country Position/Affiliation
Khartoum 00966 Sudan Professor of Obstetrics and Gynecology
Role Name Email Phone Street address
Public Enquiries Somia Khalfalla somiakhalafallah@gmail.com +249901847380 Wad Medani Hospital Road
City Postal code Country Position/Affiliation
Madani Sudan Associate Professor Of Obstetric and Gynecology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of individual participant data collected during the trial will be shared, after deidentification. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol beginning 3 months and ending 11 months following trial completion data will be shared with anyone whishes to access it, for any type of analysis or purpose and it will be available indefinitely at URL link (Link to be included)
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 18/03/2020 miss-understanding upon form filling Completed Active, not recruiting
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 19/03/2020 Its decided according to discussion with the trial team included the time and to whom IPD shall be shared Undecided Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 19/03/2020 according to the discussion, agreed by trial team All of individual participant data collected during the trial will be shared, after deidentification.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 19/03/2020 Decided along with discussion led to how to share IPD beginning 3 months and ending 11 months following trial completion
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 19/03/2020 Decided along with discussion led to share IPD data will be shared with anyone whishes to access it, for any type of analysis or purpose and it will be available indefinitely at URL link (Link to be included)
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 19/03/2020 according to the discussion and agreement by trial team which ended by this decision Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 19/03/2020 I initially thought that only an organization or official funding entity should be written in this section. Mohammed Haider Hassan Ibrahim, Medani Hospital Road, Medani, 00249, Sudan, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 19/03/2020 there was misunderstanding between active, not recruiting and not yet recruiting options. Active, not recruiting Not yet recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 19/03/2020 there was misunderstanding between active, not recruiting and not yet recruiting options. Active, not recruiting Not yet recruiting
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 19/03/2020 According to the hint below the box Women, aged ≥18 years, who diagnosed as threatened preterm labor patient and their gestational age is between 25 and 34 weeks are eligible for this trial participation. The diagnosis of threatened preterm labor is defined by uterine contractions, at least 3 contractions per 30 minutes, and one of the following: 1- a cervical length of ≤10 mm or 2) a cervical length of 11-30 mm 3- ruptured amniotic membranes. Patients with singleton or twin pregnancies are eligible, independent of the position of the fetus. Women, aged ≥18 years, who diagnosed as threatened preterm labor patient And their gestational age is between 25 and 34 weeks are eligible for this trial participation. The diagnosis of threatened preterm labor is defined by uterine contractions, at least 3 contractions per 30 minutes, and one of the following: 1- a cervical length of ≤10 mm or 2) a cervical length of 11-30 mm 3- ruptured amniotic membranes. Patients with singleton or twin pregnancies are eligible, Any fetus position will be included.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 19/03/2020 According to the hint below the box Any condition considered as contra-indication for tocolysis (i.e hypertension or use of anti-hypertensive medication, signs of fetal distress or intrauterine infection, severe vaginal bleeding, myocardial infarction (less than1 month), unstable angina pectoris), more than 5 cm cervical dilatation, cerclage, suspicion in neonatal chromosomal or structural anomalies and tocolytic treatment for more than 6 hours prior to arrival in a participating hospital. Any condition considered as contra-indication for tocolysis (i.e hypertension or use of anti-hypertensive medication, signs of fetal distress or intrauterine infection, severe vaginal bleeding, myocardial infarction (less than1 month), unstable angina pectoris), more than 5 cm cervical dilatation, cerclage, suspicion in neonatal chromosomal or structural anomalies and tocolytic treatment for more than 6 hours prior to arrival in a participating hospital.