Labour Duration and MetoclopramidePhase 4NCT04969120
Metoclopramide and the Length of First Stage of Labor , a Randomized Controlled Trial
A Phase 4 study testing Metoclopramide 10mg in people with Labour Duration and Metoclopramide, run by Cairo University at 1 site in Egypt.
Trial summary
Reducing the length of labor is a highly desirable goal of intrapartum care, both from a perspective of maternal and fetal well-being and for the providers of the birth services. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labour Duration and Metoclopramide
- What is being tested?
- Metoclopramide 10mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 1 Jul 2022
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- primigravida
- singleton pregnancy
- termgestation (37-42 weeks)
- sure reliable dated
- vertex presentation , occipito-anterior position
- regular uterine contractions at every 5 minutes,each lasting for 20 seconds
Show all 9Show fewer
- cervical dilatation of 5 cm
- with or without rupture of membrane
- no evidence of maternal or fetal distress
Who cannot join
- chorioamnionitis
- scarred uterus e.g. myomectomy
- cephalopelvic dispropotion
- history of cervical surgery or injury
- hypersensitivity to metoclopramide
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Obstetrics and gynecology department at kasralainy hospital
Cairo, 11562
About this study
Official title: The Effect of Metoclopramide on the Length of First Stage of Labor in Nulliparous Women, a Randomized Controlled Trial
Reducing the length of labor is a highly desirable goal of intrapartum care, both from a perspective of maternal and fetal well-being and for the providers of the birth services. Avoiding a long, protracted labor entails shorter exposure to pain anxiety and stress and would translate into a major improvement in maternal satisfaction with the childbirth experience.
Prolonged labor can lead to increased maternal and neonatal morbidity and mortality such as rupture of the uterus, postpartum hemorrhage, puerperal sepsis, and maternal death. Prolonged labor may be due to maternal age, premature rupture of membrane, epidural analgesia and the secretion of high levels of maternal stress hormones.
Read the detailed description
Several studies showed that active management of labor could shorten the duration of labor, and the safety of this method has been demonstrated.
Metoclopramide binds to dopamine receptors acting as a receptor antagonist, and it is also a mixed serotonin receptor agonist and antagonist.
Metoclopramide could potentially reduce spasms of the smooth muscle of the cervix that remains richly innervated at birth and thus have a regulatory effect on cervical contractility, an interaction that might be important in aiding maximal tissue compliance, promoting cervical dilatation during labor, and helping to reduce dystocia. Dopamine and other catecholamines have been identified in rabbit, rat, guinea-pig, sheep, and human uteri.
The purpose of this study is to determine the effectiveness of metoclopramide for reducing the duration of spontaneous labor among nulliparous women managed according to a standard intrapartum protocol.
- Conditions
- Labour Duration and Metoclopramide
- Being tested
- Metoclopramide 10mg, Placebo (0.9 sodium chloride)
- Keywords
- Metoclopramide - labor duration-labor pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metoclopramide 10mgDrug
this group receive 10mg intravenous metoclopramide slowly over 2 minutes the medication will be repeated every 2 hours for a maximum three doses
Placebo (0.9 sodium chloride)Drug
this group receive 10mg intravenous placebo(0.9 sodium chloride) slowly over 2 minutes the medication will be repeated every 2 hours for a maximum three doses
| Study group | Role | What they receive |
|---|---|---|
| (group 1) receiving intravenous metoclorpramide | Active comparator | this group receive 10mg intravenous metoclopramide Receives: Drug: Metoclopramide 10mg |
| (group 2) receiving placebo | Placebo comparator | this group receive 10mg intravenous placebo(0.9 sodium chloride) Receives: Drug: Placebo (0.9 sodium chloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of labour
cervical dilatation rate in first stage of labour
Measured: 8-12 hours
Secondary outcomes (1)
labour pain
effect of metoclopramide on labour pain score using visual analogue scale which is a score from 0 to 10 cm The higher the score represents more pain
Measured: pain assessment at 30,60,120 minutes following injection of metoclopramide
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start1 Mar 2022
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labour Duration and MetoclopramideStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mostafa Mohammed Refaay El shemy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969120
- Sponsor's protocol ID
- Metoclopramide and labour
- Status last verified
- Aug 2022
- First submitted
- 27 Jun 2021
- Last updated
- 2 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Metoclopramide on the Length of First Stage of Labor in Nulliparous Women, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04969120
- Acronym / sponsor ID
- Metoclopramide and labour
- Conditions
- Labour Duration and Metoclopramide
- Keywords
- Metoclopramide - labor duration-labor pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 20 Jul 2021 (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.
Reducing the length of labor is a highly desirable goal of intrapartum care, both from a perspective of maternal and fetal well-being and for the providers of the birth services. Avoiding a long, protracted labor entails shorter exposure to pain anxiety and stress and would translate into a major improvement in maternal satisfaction with the childbirth experience.
Prolonged labor can lead to increased maternal and neonatal morbidity and mortality such as rupture of the uterus, postpartum hemorrhage, puerperal sepsis, and maternal death. Prolonged labor may be due to maternal age, premature rupture of membrane, epidural analgesia and the secretion of high levels of maternal stress hormones.
Detailed description
Several studies showed that active management of labor could shorten the duration of labor, and the safety of this method has been demonstrated.
Metoclopramide binds to dopamine receptors acting as a receptor antagonist, and it is also a mixed serotonin receptor agonist and antagonist.
Metoclopramide could potentially reduce spasms of the smooth muscle of the cervix that remains richly innervated at birth and thus have a regulatory effect on cervical contractility, an interaction that might be important in aiding maximal tissue compliance, promoting cervical dilatation during labor, and helping to reduce dystocia. Dopamine and other catecholamines have been identified in rabbit, rat, guinea-pig, sheep, and human uteri.
The purpose of this study is to determine the effectiveness of metoclopramide for reducing the duration of spontaneous labor among nulliparous women managed according to a standard intrapartum protocol.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (group 1) receiving intravenous metoclorpramide | Active comparator | Drug: Metoclopramide 10mgthis group receive 10mg intravenous metoclopramide |
| (group 2) receiving placebo | Placebo comparator | Drug: Placebo (0.9 sodium chloride)this group receive 10mg intravenous placebo(0.9 sodium chloride) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- primigravida
- singleton pregnancy
- termgestation (37-42 weeks)
- sure reliable dated
- vertex presentation , occipito-anterior position
Key exclusion criteria (5 listed)
- chorioamnionitis
- scarred uterus e.g. myomectomy
- cephalopelvic dispropotion
- history of cervical surgery or injury
- hypersensitivity to metoclopramide
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 |
|---|---|---|
| Metoclopramide 10mgthis group receive 10mg intravenous metoclopramide slowly over 2 minutes the medication will be repeated every 2 hours for a maximum three doses | Drug | (group 1) receiving intravenous metoclorpramide |
| Placebo (0.9 sodium chloride)this group receive 10mg intravenous placebo(0.9 sodium chloride) slowly over 2 minutes the medication will be repeated every 2 hours for a maximum three doses | Drug | (group 2) receiving placebo |
Primary outcome
duration of labour
Time frame: 8-12 hours
cervical dilatation rate in first stage of labour
1 secondary outcome
labour pain
Time frame: pain assessment at 30,60,120 minutes following injection of metoclopramide
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 2 Aug 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Metoclopramide 10mg in people with Labour Duration and Metoclopramide, run by Cairo 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 9 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: finished, as of the sponsor's last update on 2 Aug 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 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. 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.
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?
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?
duration of labour (time frame: 8-12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2022.