An interventional study of Oxytocin 5 IU (Low Dose) and Oxytocin 10 IU (High Dose) in Postpartum Hemorrhage, Uterine Atony and Elective Cesarean Section, sponsored by Shalamar Hospital. Not yet recruiting. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Shalamar Hospital · Not applicable, Interventional, and Prevention
Uterine atony and postpartum hemorrhage are important causes of maternal morbidity and mortality following cesarean section. Oxytocin is routinely administered to stimulate uterine contractions and prevent postpartum uterine atony. However, higher doses, particularly when administered rapidly, may produce cardiovascular effects such as vasodilatation, hypotension, reflex tachycardia, and increased cardiac output. Previous studies comparing low-dose and high-dose oxytocin have reported conflicting findings regarding adequate uterine contractions and blood loss. Therefore, further investigation is required to determine the comparative effectiveness of different oxytocin doses during elective cesarean section.
The objective of this randomized controlled trial is to compare the effects of two different doses of intravenous oxytocin (5 IU and 10 IU) in patients undergoing elective cesarean section in terms of adequate uterine contractions and blood loss.
The study will be conducted in the Department of Obstetrics and Gynecology, Shalamar Hospital, Lahore, over six months after approval of the synopsis. A total of 120 pregnant women will be enrolled through non-probability consecutive sampling. Eligible participants will be aged 18-35 years, with a gestational age of 37-42 weeks, ASA physical status I or II, uncomplicated pregnancies, and scheduled for elective cesarean section under spinal anesthesia. Women with active labour, multiple pregnancy, premature rupture of membranes, pregnancy-induced hypertension, preeclampsia, increased bleeding risk, coagulation abnormalities, thrombocytopenia, or oxytocin hypersensitivity will be excluded.
After obtaining informed written consent, participants will be randomly allocated through the lottery method into two equal groups. Group A (n=60) will receive 5 IU intravenous oxytocin, while Group B (n=60) will receive 10 IU intravenous oxytocin at the time of umbilical cord clamping. The assigned dose will be diluted in 1,000 ml of normal saline or Ringer's lactate solution and administered according to the approved study protocol. All procedures will be performed by the same team to minimize procedural variation.
The primary outcomes will be adequate uterine contractions and blood loss. Adequate uterine contractions will be defined as at least one contraction at three minutes, lasting 40-60 seconds, with sufficient intensity to make the uterus feel firm on palpation. Blood loss will be measured by combining blood collected in a kidney tray and measured using a graduated cylinder with blood retained on gauze, estimated through weight difference. Secondary observations will include nausea, vomiting, hypotension, and headache.
Data will be analyzed using SPSS version 26. Numerical variables will be presented as mean and standard deviation, while categorical variables will be presented as frequencies and percentages. The chi-square test will be used for group comparisons of categorical outcomes. Stratification will be performed according to age, gestational age, and body mass index. A p-value of ≤0.05 will be considered statistically significant.
The study will help determine the comparative effectiveness of 5 IU and 10 IU intravenous oxytocin in achieving adequate uterine contractions and controlling blood loss during elective cesarean section.
Cesarean section is one of the most commonly performed obstetric surgical procedures worldwide. Uterine atony and postpartum hemorrhage are important causes of maternal morbidity and mortality following cesarean delivery. Oxytocin is routinely administered to stimulate uterine contractions and prevent postpartum uterine atony. It promotes myometrial contraction, facilitates uterine retraction, and helps achieve effective hemostasis following delivery.
Although oxytocin is widely used during cesarean section, the appropriate dose remains an important consideration. Administration of higher doses, particularly as a rapid intravenous bolus, may produce cardiovascular effects, including vasodilatation, hypotension, reflex tachycardia, and increased cardiac output. These effects may increase myocardial oxygen demand. Therefore, selecting an appropriate dose is important to achieve adequate uterine contractions while minimizing blood loss and potential adverse effects.
Previous studies comparing low-dose and high-dose oxytocin have reported inconsistent findings. Maqbool et al. reported no statistically significant difference in adequate uterine contractions or blood loss between the two dosage groups. Similarly, Somjit et al. reported comparable uterine contraction rates and no significant difference in blood loss exceeding 500 ml. However, Bhardwaj et al. reported significantly lower rates of adequate uterine contractions in the low-dose group compared with the high-dose group. These conflicting findings indicate that further investigation is required to establish the comparative effectiveness of different oxytocin doses during cesarean delivery.
The primary objective of this study is to compare the effects of two different doses of intravenous oxytocin (5 IU and 10 IU) in patients undergoing elective cesarean section in terms of adequate uterine contractions and blood loss.
This study will be conducted as a randomized controlled trial in the Department of Obstetrics and Gynecology, Shalamar Hospital, Lahore. The study duration will be six months after approval of the synopsis. A total of 120 pregnant women scheduled for elective cesarean section will be enrolled, with 60 participants allocated to each study group. The sample size has been calculated using the WHO sample size calculator, with 80% power of the test and a 5% level of significance, considering the expected frequency of adequate uterine contractions of 43.3% and 70.0% in the low-dose and high-dose oxytocin groups, respectively. Non-probability consecutive sampling will be used for participant recruitment.
Pregnant women aged 18-35 years, with a gestational age of 37-42 weeks, ASA physical status I or II, uncomplicated pregnancies, and scheduled for elective cesarean section under spinal anesthesia will be eligible for inclusion.
Women with active labour, multiple pregnancy, premature rupture of membranes, pregnancy-induced hypertension or preeclampsia will be excluded. Patients at risk of blood loss greater than 800 ml, those with inherited or acquired coagulation abnormalities or thrombocytopenia, and women with hypersensitivity to oxytocin will also be excluded.
After obtaining approval from the Hospital Ethical Review Board, eligible participants will be enrolled following informed written consent. Participants will be randomly allocated into two groups using the lottery method.
Group A (Low-Dose Oxytocin): Participants will receive 5 IU of intravenous oxytocin diluted in 1,000 ml of normal saline or Ringer's lactate solution.
Group B (High-Dose Oxytocin): Participants will receive 10 IU of intravenous oxytocin diluted in 1,000 ml of normal saline or Ringer's lactate solution.
The assigned intervention will be administered at the time of umbilical cord clamping during elective cesarean section. Administration will follow the protocol specified in the approved study synopsis. Cesarean sections will be performed according to the standard procedure of the hospital. All procedures will be performed by the same team to minimize procedural variation and potential bias. Study findings will be assessed and recorded by a senior consultant.
The primary outcome measures will be adequate uterine contractions and blood loss following administration of the assigned oxytocin dose. Adequate uterine contractions will be defined as at least one uterine contraction at three minutes after oxytocin administration, lasting 40-60 seconds, with sufficient intensity to make the uterus feel firm upon palpation, indicating effective uterine contraction and hemostasis. Blood loss will be measured by combining the volume of blood collected in a kidney tray, subsequently measured using a graduated cylinder, and blood retained on soaked gauze. Blood retained on gauze will be estimated by subtracting the weight of unused gauze from the weight of soaked gauze, using the study protocol's conversion of 1 mg to 1 ml. Additional observations will include the occurrence of complications such as nausea, vomiting, hypotension, and headache. Demographic and clinical variables, including maternal age, gestational age, and body mass index, will also be recorded.
All collected data will be entered and analyzed using Statistical Package for the Social Sciences (SPSS), version 26. Numerical variables, including age, gestational age, body mass index, and blood loss, will be presented as mean and standard deviation. Categorical variables, including adequate uterine contractions and complications, will be presented as frequencies and percentages.
The frequency of adequate uterine contractions will be compared between the two groups using the chi-square test. Stratification will be performed according to age, gestational age, and body mass index to address potential effect modifiers. Post-stratification comparisons will also be performed using the chi-square test. A p-value of ≤0.05 will be considered statistically significant. This study will provide comparative evidence regarding the effects of 5 IU and 10 IU intravenous oxytocin in women undergoing elective cesarean section. By evaluating adequate uterine contractions, blood loss, and associated complications, the study will help clarify the effectiveness of the two dosage regimens and may contribute to selecting an appropriate oxytocin dose in future obstetric practice.
469 studies on the registry are indexed under Postpartum Hemorrhage; 76 are open to participants now.
This study's planned enrollment of 120 is below the median of 148 across 360 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →Shalamar Hospital is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will receive 5 IU of intravenous oxytocin diluted in 1,000 ml of normal saline or Ringer's lactate solution at the time of umbilical cord clamping during elective cesarean section. The assigned dose will be administered according to the approved study protocol. Adequate uterine contractions, blood loss, and associated complications will be assessed and recorded.
Drug: Oxytocin 5 IU (Low Dose)
Participants in this group will receive 10 IU of intravenous oxytocin diluted in 1,000 ml of normal saline or Ringer's lactate solution at the time of umbilical cord clamping during elective cesarean section. The assigned dose will be administered according to the approved study protocol. Adequate uterine contractions, blood loss, and associated complications will be assessed and recorded.
Drug: Oxytocin 10 IU (High Dose)
Oxytocin 5 IU will be administered intravenously to participants undergoing elective cesarean section at the time of umbilical cord clamping. The dose will be diluted in 1,000 ml of normal saline or Ringer's lactate solution and administered as specified in the approved study protocol. The intervention aims to promote adequate uterine contractions and minimize blood loss following delivery.
Oxytocin 10 IU will be administered intravenously to participants undergoing elective cesarean section at the time of umbilical cord clamping. The dose will be diluted in 1,000 ml of normal saline or Ringer's lactate solution and administered as specified in the approved study protocol. The intervention aims to promote adequate uterine contractions and minimize blood loss following delivery.
Adequate Uterine Contractions
Adequate uterine contractions will be assessed at 3 minutes after oxytocin administration. Adequacy will be defined as at least one uterine contraction lasting 40-60 seconds, with sufficient intensity to make the uterus feel firm upon palpation.
Time frame: 3 minutes after oxytocin administration.
Frequency of Nausea
Occurrence of nausea following administration of oxytocin.
Time frame: Intraoperative period.
Frequency of Vomiting
Occurrence of vomiting following administration of oxytocin.
Time frame: Intraoperative period.
Frequency of Hypotension
Occurrence of hypotension following administration of oxytocin.
Time frame: Intraoperative period.
Frequency of Headache
Occurrence of headache following administration of oxytocin.
Time frame: Intraoperative period
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared publicly. The data will be used solely for research and statistical analysis in accordance with institutional ethical requirements and participant confidentiality. No individual participant information will be disclosed.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shalamar Hospital