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| ID | Type | Description | Link |
|---|---|---|---|
| PARACETAMOL-INTRAPARTUM | Other Identifier | Pharma Tech company |
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This is a double-blind randomized trial evaluates the efficacy of intravenous infusion of Paracetamol as intrapartum analgesic in the first stage of labour.
Comparison of efficacy and safety of intravenous infusion of paracetamol versus placebo (intravenous sterile water infusion) in parturient women in active first phase of labour and requiring intrapartum analgesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (1) Active (Paracetamol) arm: n=60 | Active Comparator | (Paracetamol) |
|
| (2) Placbo (Sterile water) arm: n=60 | Placebo Comparator | Sterile water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (1) Paracetamol injection | Drug | Drugs: (1) Bottle containing 1000 mg Paracetamol in 100 ml solution for intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the efficacy of intravenous infusion of paracetamol in comparison with placebo (sterile water for injection) in labouring women | By recoding the need for a rescue additional analgesia and measuring the degree of pain relief (Visual analogue score) during the labor process. | Start of medication till end of first stage of labour. Participants will be followed for the duration of labour, an expected average of 8 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| To document safety | By assessing the adverse events recorded during the study either maternal or fetal/neonatal. | Start of medication till delivery and neonatal assesment. Participants will be followed during this duration of labour, an expected average of 10 hours. |
| To correlate with the duration of labor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed E Elbohoty, MD | OB GYN Department, faculty of Medicine, ASU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams Maternity Hospital | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25132459 | Derived | Abd-El-Maeboud KH, Elbohoty AE, Mohammed WE, Elgamel HM, Ali WA. Intravenous infusion of paracetamol for intrapartum analgesia. J Obstet Gynaecol Res. 2014 Nov;40(11):2152-7. doi: 10.1111/jog.12465. Epub 2014 Aug 11. |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Sterile water | Other | Drugs: (2) Bottle containing 100 ml sterile water for intravenous infusion |
|
The difference between both groups regarding labour duration |
| Start of medication till end of second stage of labour. Participants will be followed for the duration of labour, an expected average of 9 hours. |
| Aniline Compounds |
| D000588 | Amines |