Prolonged First Stage of LaborPhase 4NCT01937234
Use of an Antiemetic to Shorten the Length of Labor in Nulliparous Women
A Phase 4 study testing Metoclopramide in people with Prolonged First Stage of Labor, run by Ain Shams University at 1 site in Saudi Arabia.
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?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Prolonged First Stage of Labor
- What is being tested?
- Metoclopramide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jul 2013to Sep 2016
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primigravida
- Singleton pregnancy
- Term gestation i.e. 37- 42 weeks
- Sure reliable dates
- Vertex presentation, occipitoanterior position
- Spontaneous onset of labor
Show all 10Show fewer
- Regular uterine contractions at every 5 min ,each lasting for 20 sec
- Cervical dilatation of 3-5cm
- With or without rupture of membranes
- No evidence of maternal or fetal distress
Who cannot join
- Mal-presentations
- Mal-positions
- Multifetal pregnancy
- Cephalopelvic disproportion
- history of cervical surgery or injury
- Hypersensitivity to metoclopramide
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Labor and delivery ward of Armed Forces Hospital, Southern Region.
Khamis Mushait, Khamis Mushait, 101
About this study
Official title: Use of an Antiemetic to Shorten the Length of Labor in Nulliparous Women, Exploring a Potential Role of an Old Drug
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 child birth experience.
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.
Read the detailed description
Women who will fulfill the study inclusion and exclusion criteria and agree to be included in the study will be randomized assigned to receive either an intravenous injection of 10mg metoclopramide (Group 1) or the same volume of placebo, i.e. 0.9% sodium chloride (Group2). Randomization will be achieved using computer generated randomization sequences. Allocation will be in 1:1 ratio. Record of group allocation will be maintained by a resident physician whose responsibility is randomization and drawing up the injection, but has no direct involvement in the intrapartum decision making.
After through history and physical examination, each participant will take the selected medication slowly IV over 2 min, the assigned medication will be repeated every two hours for a maximum of three doses.
Monitoring of fetal well-being and labor progress with Partographic representation will be performed.
Management of labor will be according the labor and delivery standard protocol, if labor dilatation will not progress appropriately, i.e. cervical dilatation rate of <1cm/hour, amniotomy will be performed if membranes are intact. Oxytocin augmentation will be considered after rupture of membranes only if the cervix remains unchanged on two consecutive pelvic examination conducted two hours apart. Oxytocin infusion will start with 5mIU/min and increase by 5mIU/min every 15min to achieve seven contractions in 15 min, the maximal rate of oxytocin being 30Miu/min.
The following parameters will be recorded for every patient:
- Timing of metoclopramide or placebo injections
- Timing of full dilatation of cervix
- Duration of first stage of labor
- Duration of second stage of labor
- Duration of third stage of labor
- Mode of delivery
- Injection to delivery interval
- Cervical dilatation rate
- Neonatal condition at birth
- Conditions
- Prolonged First Stage of Labor
- Being tested
- Metoclopramide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoclopramideDrug
Also called Primperan (Trademark)
Intravenous injection of 10mg metoclopramide, at enrollment, then every 2 hours.
Maximum of 3 doses.
PlaceboDrug
Also called Normal saline
Intravenous injection of 0.9% sodium chloride, at enrollment, then every 2 hours.
Maximum of 3 doses.
| Study group | Role | What they receive |
|---|---|---|
| Metoclopramide | Active comparator | Intravenous injection of 10mg metoclopramide Receives: Drug: Metoclopramide |
| Placebo | Placebo comparator | Intravenous injection of 0.9% sodium chloride Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical dilatation rate
Measured: 6 hours
Secondary outcomes (1)
Duration of the first stage of labor
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2016
- Study completionSep 2016
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 Prolonged First Stage of LaborStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Armed Forces Hospitals, Southern Region, Saudi Arabia
- Responsible party
- Principal investigator, Mohamed Ellaithy, Ain Shams University
- Investigators
- Mohamed I Ellaithy, MD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937234
- Sponsor's protocol ID
- AFHSR-13-7-2013
- Status last verified
- Mar 2017
- First submitted
- 1 Sep 2013
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ellaithy M, Rasheed S, Shafik A, Abees S. Use of an antiemetic to shorten the length of labor in nulliparous women, exploring a potential role of an old drug: A randomized controlled trial. Int J Gynaecol Obstet. 2020 Jan;148(1):72-78. doi: 10.1002/ijgo.12998. Epub 2019 Nov 8.
PubMed 31609464
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an Antiemetic to Shorten the Length of Labor in Nulliparous Women, Exploring a Potential Role of an Old Drug
- ClinicalTrials.gov ID
- NCT01937234
- Acronym / sponsor ID
- AFHSR-13-7-2013
- Conditions
- Prolonged First Stage of Labor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Armed Forces Hospitals, Southern Region, Saudi Arabia
- Study start
- Jul 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 9 Sep 2013 (estimated)
- 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 child birth experience.
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.
Detailed description
Women who will fulfill the study inclusion and exclusion criteria and agree to be included in the study will be randomized assigned to receive either an intravenous injection of 10mg metoclopramide (Group 1) or the same volume of placebo, i.e. 0.9% sodium chloride (Group2). Randomization will be achieved using computer generated randomization sequences. Allocation will be in 1:1 ratio. Record of group allocation will be maintained by a resident physician whose responsibility is randomization and drawing up the injection, but has no direct involvement in the intrapartum decision making.
After through history and physical examination, each participant will take the selected medication slowly IV over 2 min, the assigned medication will be repeated every two hours for a maximum of three doses.
Monitoring of fetal well-being and labor progress with Partographic representation will be performed.
Management of labor will be according the labor and delivery standard protocol, if labor dilatation will not progress appropriately, i.e. cervical dilatation rate of <1cm/hour, amniotomy will be performed if membranes are intact. Oxytocin augmentation will be considered after rupture of membranes only if the cervix remains unchanged on two consecutive pelvic examination conducted two hours apart. Oxytocin infusion will start with 5mIU/min and increase by 5mIU/min every 15min to achieve seven contractions in 15 min, the maximal rate of oxytocin being 30Miu/min.
The following parameters will be recorded for every patient:
- Timing of metoclopramide or placebo injections
- Timing of full dilatation of cervix
- Duration of first stage of labor
- Duration of second stage of labor
- Duration of third stage of labor
- Mode of delivery
- Injection to delivery interval
- Cervical dilatation rate
- Neonatal condition at birth
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metoclopramide | Active comparator | Drug: MetoclopramideIntravenous injection of 10mg metoclopramide |
| Placebo | Placebo comparator | Drug: PlaceboIntravenous injection of 0.9% sodium chloride |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Primigravida
- Singleton pregnancy
- Term gestation i.e. 37- 42 weeks
- Sure reliable dates
- Vertex presentation, occipitoanterior position
Key exclusion criteria (6 listed)
- Mal-presentations
- Mal-positions
- Multifetal pregnancy
- Cephalopelvic disproportion
- history of cervical surgery or injury
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 |
|---|---|---|
| MetoclopramideAlso: Primperan (Trademark)Intravenous injection of 10mg metoclopramide, at enrollment, then every 2 hours. Maximum of 3 doses. | Drug | Metoclopramide |
| PlaceboAlso: Normal salineIntravenous injection of 0.9% sodium chloride, at enrollment, then every 2 hours. Maximum of 3 doses. | Drug | Placebo |
Primary outcome
Cervical dilatation rate
Time frame: 6 hours
1 secondary outcome
Duration of the first stage of labor
Time frame: 6 hours
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 10 Mar 2017.
- Derived from this study: PubMed 31609464Ellaithy M, Rasheed S, Shafik A, Abees S. Use of an antiemetic to shorten the length of labor in nulliparous women, exploring a potential role of an old drug: A randomized controlled trial. Int J Gynaecol Obstet. 2020 Jan;148(1):72-78. doi: 10.1002/ijgo.12998. Epub 2019 Nov 8.
Related trials for Prolonged First Stage of Labor
Recruiting
Maternal Maneuvers During Prolonged Labor
Labor Stage, First, Prolonged Labor
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.
Mohamed I Ellaithy, MD study director
Ain Shams University
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 in people with Prolonged First Stage of Labor, run by Ain Shams University at 1 site in Saudi Arabia.
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 10 inclusion and 6 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 10 Mar 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 Saudi Arabia. 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?
Cervical dilatation rate (time frame: 6 hours). 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 NCT01937234, 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 10 Mar 2017; AzTrials last refreshed its copy on 8 Nov 2026.