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| Name | Class |
|---|---|
| Armed Forces Hospitals, Southern Region, Saudi Arabia | OTHER_GOV |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metoclopramide | Active Comparator | Intravenous injection of 10mg metoclopramide |
|
| Placebo | Placebo Comparator | Intravenous injection of 0.9% sodium chloride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoclopramide | Drug | Intravenous injection of 10mg metoclopramide, at enrollment, then every 2 hours. Maximum of 3 doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cervical dilatation rate | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of the first stage of labor | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of the second stage of labor | 2 hours | |
| Duration of the third stage of labor | 1 hour | |
| Number of Participants with Adverse Events |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed I Ellaithy, MD | Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Labor and delivery ward of Armed Forces Hospital, Southern Region. | Khamis Mushait | Khamis Mushait | 101 | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31609464 | Derived | 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. |
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| ID | Term |
|---|---|
| D008787 | Metoclopramide |
| D010330 | Patents as Topic |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
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| Placebo | Drug | Intravenous injection of 0.9% sodium chloride, at enrollment, then every 2 hours. Maximum of 3 doses. |
|
|
Adverse effects of metoclopramide:
|
| 24 hours |
| Apgar score | 10 minutes |
| Meconium stained liquor | 6 hours |
| Neonatal intensive care unit admission rate | 24 hours |
| Rate of vaginal delivery | 12 hours |
| Number of participants with genital tract injuries | genital tract injuries:
| 2 hours |
| D062365 |
| Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
| D018973 | Intellectual Property |
| D007603 | Jurisprudence |
| D012926 | Social Control, Formal |
| D004472 | Health Care Economics and Organizations |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |