ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessing Maternal Post-partum Pain With Suppositories (CRAMPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01271855
Recruitment Status : Completed
First Posted : January 7, 2011
Results First Posted : February 6, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Loyola University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pain
Interventions: Drug: Belladonna and opioid suppository
Drug: Glycerin Suppository

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
For this study, participants were recruited between August 1, 2009 and October 1, 2011 (26 months)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Glycerin Suppository Women assigned to this arm receive a vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
Belladonna and Opioid Suppository Women assigned to this arm receive a Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery

Participant Flow:   Overall Study
    Glycerin Suppository   Belladonna and Opioid Suppository
STARTED   48   52 
COMPLETED   48   52 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Glycerin Suppository Women assigned to this arm receive a vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
Belladonna and Opioid Suppository Women assigned to this arm receive a Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery
Total Total of all reporting groups

Baseline Measures
   Glycerin Suppository   Belladonna and Opioid Suppository   Total 
Overall Participants Analyzed 
[Units: Participants]
 48   52   100 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed   48   52   100 
   29.40  (5.78)   29.29  (5.76)   29.34  (5.74) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed   48   52   100 
Female      48 100.0%      52 100.0%      100 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed   48   52   100 
Hispanic or Latino      17  35.4%      19  36.5%      36  36.0% 
Not Hispanic or Latino      24  50.0%      22  42.3%      46  46.0% 
Unknown or Not Reported      7  14.6%      11  21.2%      18  18.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Asian       
Participants Analyzed   48   52   100 
Asian   0   1   1 
Black or African American       
Participants Analyzed   48   52   100 
Black or African American   7   6   13 
White       
Participants Analyzed   48   52   100 
White   24   25   49 
Other Race       
Participants Analyzed   48   52   100 
Other Race   2   7   9 
Unknown or Not Reported       
Participants Analyzed   48   52   100 
Unknown or Not Reported   15   13   28 
Region of Enrollment 
[Units: Participants]
     
United States       
Participants Analyzed   48   52   100 
United States   48   52   100 
Gravidity 
[Units: Count of pregnancies]
Median (Inter-Quartile Range)
     
Participants Analyzed   48   52   100 
   2.5 
 (2 to 3) 
 2 
 (1 to 3) 
 2 
 (2 to 3) 
Parity [1] 
[Units: Pregnancies to a viable gestational age]
Median (Inter-Quartile Range)
     
Participants Analyzed   48   51   99 
   1 
 (1 to 2) 
 1 
 (0 to 2) 
 1 
 (0 to 2) 
[1] The parity count for one participant in the Belladonna and opioid suppository group is unknown
Gestational Age [1] 
[Units: Weeks]
Mean (Standard Deviation)
     
Participants Analyzed   47   51   98 
   38.68  (1.24)   39.09  (1.05)   38.89  (1.16) 
[1] The gestational age for one participant in the Belladonna and opioid suppository group is unknown, and the gestational age for one participant in the Glycerin suppository group is unknown
Route of Delivery 
[Units: Participants]
Count of Participants
     
Participants Analyzed   48   52   100 
Normal spontaneous vaginal delivery (NSVD)      31  64.6%      42  80.8%      73  73.0% 
Cesarean      17  35.4%      10  19.2%      27  27.0% 
Breastfeeding 
[Units: Participants]
Count of Participants
     
Participants Analyzed   48   52   100 
Breastfeeding      37  77.1%      41  78.8%      78  78.0% 
Not Breastfeeding      8  16.7%      9  17.3%      17  17.0% 
Breastfeeding is unknown or not reported      3   6.3%      2   3.8%      5   5.0% 
Visual Analogue Scale Pain Score [1] [2] 
[Units: Units on a scale]
Median (Inter-Quartile Range)
     
Participants Analyzed   47   50   97 
   0 
 (0 to 2) 
 0 
 (0 to 4) 
 0 
 (0 to 4) 
[1] Patients' baseline Visual Analog Scale (VAS) pain score was recorded at 0 hours after delivery. This scale ranges from 0 to 10 (0=no pain and 10=worst pain).
[2] The baseline visual analogue pain score for two participants in the Belladonna and opioid suppository group is unknown, and the baseline visual analogue pain score for one participant in the Glycerin suppository group is unknown


  Outcome Measures

1.  Primary:   Pain Level Twenty Four Hours After Delivery   [ Time Frame: Twenty-four hours ]

2.  Secondary:   Number of Patients Taking Additional Pain Medications   [ Time Frame: Twenty-four hours ]

3.  Secondary:   Patient Satisfaction   [ Time Frame: Discharge ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There are no limitations or caveats to report


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kimberly Kenton MD, MS
Organization: Northwestern University
phone: 312-472-3874
e-mail: kkenton@nm.org


Publications:

Responsible Party: Loyola University
ClinicalTrials.gov Identifier: NCT01271855     History of Changes
Other Study ID Numbers: 201720
First Submitted: January 5, 2011
First Posted: January 7, 2011
Results First Submitted: January 8, 2018
Results First Posted: February 6, 2018
Last Update Posted: March 7, 2018